MEDTECH

LAWS
 [ REPUBLIC ACT NO. 5527, June 21, 1969 ]

AN ACT REQUIRING THE REGISTRATION OF MEDICAL TECHNOLOGISTS,

DEFINING THEIR PRACTICE, AND FOR OTHER PURPOSES.

Be it enacted by the Senate and House of Representatives of the Philippines in

Congress assembled:

SECTION 1. Title.—This Act may be also cited as the Philippine Medical Technology
Act of 1969.

SEC. 2. Definition of Terms.—As used in this Act, the following terms shall mean:

(a) "Medical Technology".—An auxiliary branch of laboratory medicine which deals with
the examination by various chemical, microscopic, bacteriologic and other medical
laboratory procedures or technic which will aid the physician in the diagnosis, study and
treatment of disease and in the promotion of health in general.

(b) "Pathologist".—A duly registered physician who is specially trained in methods of

laboratory medicine, or the gross and microscopic study and interpretation of tissues,
secretions and excretions of the human body and its functions in order to diagnose
disease, follow its course, determine the effectivity of treatment, ascertain cause of
death and advance medicine by means of research.

(c) "Medical Technologist".—A person who engages in the work of medical technology
under the supervision of a pathologist or licensed physician authorized by the
department of health in places where there is no pathologist and who having passed a
prescribed course (Bachelor of Science in Medical Technology/Bachelor of Science in
Hygiene) of training and examination is registered under the provision of this Act.

(d) "Medical Technician".—A person who not being a graduate of Bachelor of Science in
Medical Technology/ Bachelor of Science in Hygiene, but having passed the
corresponding civil service examination, performs the work of medical technology
under the supervision of a registered medical technologist and/or qualified pathologist.

(e) "Accredited Medical Technology Training Laboratory—A clinical laboratory, office,

agency, clinic, hospital or sanitarium duly approved by the Department of Health or its
authorized agency.

(f) "Recognized School of Medical Technology".—Any school, college or university

which offers a course in Medical Technology approved by the Department of Education
in accordance with the requirements under this Act, upon recommendation of the
council of medical technology education.
(g) "Council".—The council of medical technology education established under this Act.

(h) "Board".—The Board of Examiners for Medical Technology established under this
Act.
SEC. 3. Council of Medical Technology Education, Its Composition.—There is hereby
established a Council of Medical Technology Education, hereafter referred to as
Council, which shall be composed of the Secretary of Education or Director of Private
Education as Chairman, the Director of the Bureau of Research and Laboratories of the
Department of Health as Vice-Chairman, and the Chairman and two members of the
Board of Medical Technology, the dean of ,the Institute of Hygiene of the University of
the Philippines, a representative of the deans or heads of the private schools of medical
technology, and the presidents of the Philippine Association of Medical Technologists
and the Philippine Society of Pathologists, as members.

SEC. 4. Compensation and Traveling Expenses of Council Members.—The chairman

and members of the Council shall be entitled to a twenty-five pesos per diem for every
meeting actually attended: Provided, That the number of meetings authorized with
a per diem shall not exceed two in a month: And Provided, further, That officials
receiving regular salaries from the Government shall not receive per diem. In addition
the chairman and members of the council shall be entitled to traveling expenses in
connection with their official duties.

SEC. 5. Functions of the Council of Medical Technology Education.—The functions of

the Council shall be:

(a) To recommend the minimum required curriculum for the course of medical
technology.

(b) To determine and prescribe the number of students to be allowed to take up the
medical technology course in each school, taking into account the student-instructor
ratio and the availability of facilities for instruction.

(c) To approve medical technology schools meeting the requirements and recommend
closure of those found to be substandard.

(d) To require all medical technology schools to submit an annual report, including the
total number of students and instructors, a list of facilities available for instruction, a list
of their recent graduates and new admissions, on or "before the month of June.

(e) To inspect, when necessary, the different medical technology schools in the country
in order to determine whether a high standard of education is maintained in said
institutions.

(f) To certify for admission into an undergraduate internship students who have
satisfactorily completed three years of the medical technology course or its equivalent
and to collect from said students the amount of five pesos each which money accrue to
the operating fund of the council.

(g) Formulate and recommend approval of refresher course for applicants who shall
have failed the Board Examination for the third time.

(h) To promulgate and prescribe and enforce necessary rules and regulations for the
proper implementation of the foregoing functions.
SEC. 6. Minimum Required Course.—The medical technology course shall be at least
four years, including a 12-month satisfctory internship in accredited laboratories, and
shall include the following subjects:

English Biochemistry
Spanish Gross Anatomy
Social Science Histology
General Zoology Physiology
Botany Clinical Parasitology
Mathematics General Pathology
College Physics Microbiology
General Chemistry Biostatistics
Qualitative Chemistry Clinical Laboratory Methods
including hemotology,
serology, blood banking,
clinical microscopy, applied
Quantitative Chemistry microbiology, and
parasitology, histopathologic
techniques, and cyto-
technology.

The Council is hereby authorized, subject to the approval of the Secretary of Education
to change, remove from or add to the subjects listed above as the needs and demands
of progress in the science of medical technology may require.

SEC. 7. Board of Examiners for Medical Technology.— There is hereby created a

Board of Examiners for Medical Technology which shall hereafter be referred to as the
Board composed of a chairman who is a pathologist appointed by the President of the
Philippines from a list submitted by the Philippine Society of Pathologists and two
members who are registered medical technologists appointed by the President of the
Philippines from among a list submitted by the Philippine Association of Medical
Technologists each one to serve a term of three years: Provided, That the first .Board to
be created one member who shall act as chairman shall serve for three years, one
member for two years and the third member for one year: And provided, further, That
the first members of the Board of Examiners for Medical Technology shall be issued a
certificate of registration as Medical Technologist without prior examination in
accordance with the provisions of this Act. No member shall be allowed more than one
reappointment. The President of the Philippines shall fill the vacancy that may occur but
the appointee shall serve only the unexpired term of the incapacitated member.
SEC. 8. Qualifications of Examiners.—No person shall be appointed a member of the
Board of Examiners for Medical Technology unless he or she (1) is a Filipino citizen; (2)
is of good moral character; (3) is a qualified pathologist or duly registered medical
technologist of the Philippines with the degree of Bachelor of Science in Medical
Technology/Bachelor of Science in Hygiene; (4) has been in the practice of laboratory
medicine or medical technology for at least ten years prior to his appointment, and (5) is
not a member of the faculty of any medical technology school, or have any pecuniary
interest, direct or indirect, in such institution: Provided, however, That for the first three
years following the approval of this Act, the requirement mentioned in number four (4)
shall be reduced to five years.

SEC. 9. Executive Officer of the Board.—The Commissioner of Civil Service shall be the
Executive Officer of the Board, and shall conduct the examinations given by it. The
Secretary of the Board of Examiners appointed in accordance with Section ten of Act
Numbered Four Thousand Seven, as amended, shall also be the Secretary of the
Board. He shall keep a register of all persons to whom certificates of registration have
been granted.

SEC. 10. Compensation of Members of the Board of Examiners for Medical

Technology.—Each member of the Board shall receive a sum of ten pesos for each
applicant examined and five pesos for each applicant granted a certificate of registration
without examination.

SEC. 11. Functions and Duties of the Board.—The Board is vested with authority and
required, conformably with the provisions of this Act, to:

(a) Administer the provisions of this Act;

(b) Administer oaths in connection with the administration of this Act;

(c) Issue, suspend and revoke certificates of registration for the practice of medical
technology;

(d) Look into conditions affecting the practice of medical technology in the Philippines
and, whenever necessary, adopt such measures as may be deemed proper for the
maintenance of good ethics and standards in the practice of medical technology;

(e) Investigate such violations of this Act or of the rules and regulations issued
thereunder as may come to the knowledge of the Board and, for this purpose
issue subpoena and subpoena duces tecum to secure appearance of witnesses and
production of documents in connection with charges presented to the Board; and

(f) Draft such rules and regulations as may be necessary to carry out the provisions of
this Act: Provided, That the same shall be issued only after the approval of the
President of the Philippines.
SEC. 12. Removal of Board Members.—Any member of the Board may be removed by
the President of the Philippines for neglect of duty, incompetency, malpractice or
unprofessional, unethical, immoral or dishonorable conduct after having been given
opportunity to defend himself in a proper administrative investigation; Provided, That
during the process of investigation, the President shall have the power to suspend such
member under investigation and appoint a temporary member in his place.

SEC. 13. Accreditation of Schools of Medical Technology and of Training

Laboratories.—Department of Education shall approve schools of medical technology in
accordance with the provisions of this Act. The Department of Health or its authorized
agency shall upon recommendation of the Council of Medical Technology Education
approve laboratories for accreditation as training laboratories for Medical Technology
students or postgraduate trainees upon satisfactory evidence that said laboratories
possess qualified personnel and are properly equipped to carry out laboratory
procedures commonly required in the following fields: bacteriology, serology,
parasitology, hematology, and biochemistry, and that the scope of activities of said
laboratory offer sufficient training in said laboratory procedures.

SEC. 14. Inhibition Against the Practice of Medical Technology.—No person shall
practice or offer to practice medical technology as denned in this Act without having
previously obtained a valid certificate of registration from the Board provided that
registration shall not be required of the following:

(a) Duly registered physicians.

(b) Medical technologists from other countries, called in for consultation or as visiting or
exchange professors to colleges or universities: Provided, That they are only practicing
the said function.

(c) Medical technologists in the service of the United States Armed Forces stationed in
the Philippines rendering services as such for members of the said forces only.
SEC. 15. Examination.—Except as otherwise specifically allowed under the provisions
of this Act, all applicants for registration as medical technologists shall be required to
undergo a written examination which shall be given by the Board annually in the greater
Manila area, Cebu and Davao during the month of August or September on such days
and places as the Board may designate. Written notices of such examination shall be
published in at least three newspapers of national circulation by the Secretary of the
Board at least thirty days prior to the date of examination.

SEC. 16. Qualification for Examination.—Every applicant for examination under this Act,
shall, prior to the date thereof, furnish the Board satisfactory proof that he or she:

(a) Is in good health and is of good moral character;

(b) Has completed a course of at least four years leading to the degrees of Bachelor of
Science in Medical Technology or Bachelor of Science in Hygiene conferred by a
recognized school, college or university in accordance with this Act and all other
persons having graduated from other paramedical professions who are actually
performing medical technology for the last five years prior to the enactment of this Act
provided they meet the minimum requirements mentioned in Section Six except the one
year undergraduate internship or practical training.
SEC. 17. Scope of Examination.—The examination question shall cover the following
subjects with their respective relative weights:

Clinical Chemistry 20%

Microbiology and Parasitology 20%
Hematology 20%
Blood Banking and Serology 20%
Clinical Microscopy (Urinalysis and other body
10%
fluids)
Histopathologic Technique 10%

The Board shall prepare the schedule of subjects for examination and to submit the
same to the Commissioner of Civil Service for publication at least four months before
the date of examination. The Board shall compute the general average of each
examinee according to the above-mentioned relative weights of the subjects: Provided,
however, That the Board may change, add to or remove from the list of subjects or
weights above, as progress in the science of medical technology may require, subject to
the prior approval of the Council.

SEC. 18. Report of Rating.—The Board shall, within one hundred and twenty days after
the date of completion of the examination, report the result thereof to the Commissioner
of Civil Service, who shall submit such result to the President of the Philippines for
approval

SEC. 19. Ratings in the Examination.—In order to pass the examination, a candidate
must obtain a general average of at least seventy-five per cent in the written test, with
no rating below fifty per cent in any of the major subjects: Provided, That the candidate
has not failed in at least sixty per cent of the subjects computed according to their
relative weights. No further examination will be given an applicant who has not qualified
after three examinations, unless and until he shall have completed 12 months refresher
course in an accredited medical technology school or 12-month postgraduate training in
an accredited laboratory:Provided, That graduate of paramedical professions other than
Bachelor of Science in Medical Technology/Bachelor of Science in Hygiene admitted to
an examination under the provisions of this Act shall not be given further examinations
after his failure to qualify for the third time.

SEC. 20. Oath Taking.—All successful examinees shall be required to take a

professional oath before the Board or before any person authorized to administer oaths
prior to entering upon the practice of medical technology in the Philippines.

SEC. 21. Issuance of Certificate of Registration.— Every applicant who has

satisfactorily passed the required examination, shall be issued a certificate of
registration as Medical Technologist: Provided, That no such certificate shall be issued
to any successful applicant who has not attained the age of twenty-one years. All
certificates shall be signed by all the members of the Board and attested by its
Secretary. The duly registered medical technologist shall be required to display his
certificate of registration in the place where he works. Upon application filed after the
approval of this Act not later than ninety days after the Board shall have been fully
constituted, the Board shall issue a certificate of registration without examination to
persons who have been graduated with a Bachelor of Science in Hygiene and/or
Bachelor of Science in Medical. Technology in duly recognized schools of medical
technology in the Philippines or foreign countries who have been in the practice of
medical technology for at least three years at the time of the passage of this Act in
laboratories in the Philippines or in foreign countries duly accredited by the Bureau of
Research and Laboratories, Department of Health, and also to all other persons having
graduated from other paramedical professions who are already civil service eligible by
authority of the other Boards of profession and who are actually performing medical
technology practice for the last five years prior to the enactment of this Act.

SEC. 22. Fees.—The Board shall charge each applicant for examination and
registration the sum of fifty pesos and for each certificate of registration issued without
prior examination in accordance with the provisions of this Act the sum of twenty-five
pesos; for issuance of a new certificate to replace certificate lost, destroyed or
mutilated, the Board shall charge the sum of ten pesos. All such fees shall be paid to
the disbursing officer of the Civil Service Commission who shall pay from the receipts
thereof, all authorized expenses of the Board including the compensation of each
member.

SEC. 23. Refusal to Issue Certificate.—The Board shall refuse to issue a certificate of
registration to any person convicted by a court of competent jurisdiction of any criminal
offense involving moral turpitude, or any person guilty of immoral or dishonorable
conduct, or of unsound mind, or incurable communicable disease, and in such case
shall give to the applicant a written statement setting forth the reason for its action,
which statement shall be incorporated in the record of the Board.

SEC. 24. Administrative Investigation-Revocation or Suspension of Certificates:—

Administrative investigations shall be conducted by at least two members of the Board
with one legal officer sitting during the investigation. The existing rules of evidence shall
be observed during all administrative proceedings, the respondents shall be entitled to
be represented by counsel, or be heard in person, to have a speedy and public hearing,
to confront and cross-examine witnesses against him or her, and to all other rights
guaranteed by the Constitution.

The Board may, after giving proper notice and hearing to the party concerned reprimand
an erring medical technologist or revoke or suspend his certificate of registration for the
causes mentioned in the next preceding section or for causes enumerated in section
twenty-nine (29) of this Act, or for unprofessional conduct, malpractice, incompetency,
or serious ignorance or gross negligence in the practice of medical technology.

No penalty of revocation shall be imposed unless there is a unanimous vote of all the
three members of the Board. The Board may, by majority vote, impose the penalty
of reprimand or suspension, the latter however not to exceed two years.

When the penalty of suspension or revocation is imposed by the Board the medical
technologist shall be required to surrender his certificate of registration within thirty days
after the decision becomes final, under the pain of perpetual disqualification from the
practice of medical technology in the Philippines for inexcusable failure to do so. The
suspension shall run from the date of such surrender.

SEC. 25. Appeal.—The revocation or suspension of a certificate made by the Board

shall be subject to appeal to the Civil Service Commissioner whose decision shall
become final thirty days after its promulgation, unless the respondent within the same
period has appealed to the office of the President of the Philippines.

SEC. 26. Reinstatement, Reissue or Replacement of Certificates.—The Board may,

upon application and for reason deemed proper and sufficient, reissue any revoked
registration certificate. The suspension of a certificate of , registration shall be
automatically lifted upon the expiration of the period of suspension and said certificate
shall be re-issued to the medical technologist concerned upon request without prejudice
to further actions by the Board for violation of the provisions of this Act or conditions
imposed by the Board upon the medical technologist during the period of suspension.

SEC. 27. Foreign Reciprocity.—No foreigner shall be admitted to examination, or be

given a certificate of registration or be entitled to any of the rights and privileges under
this Act, unless the country or state of which he is a subject or a citizen permits Filipino
Medical Technologists to practice within territorial limits on the same basis as the
subjects or citizens of said country or state.

SEC. 28. Roster of Medical Technologists.—A roster of Medical Technologists shall, be

prepared annually by the Secretary of the Board, commencing on the year following that
in which this Act shall become effective. This roster shall contain the name, address and
citizenship of each registered Medical Technologist, date of registration or issuance of
certificate, and other data which in the opinion of the Board are pertinent. The roster
shall be open to public inspection, and copies thereof shall be mailed to each person
included therein, placed on file in the Office of the President, furnished all Department
Heads and all bureaus, offices and instrumentalities of the Department of Health and to
such other offices, private or governmental, and to the public upon request.

SEC. 29. Penal Provisions.—Without prejudice to the provision of the Medical Act of
1959 as amended relating to illegal practice of Medicine, the following shall be punished
by a fine of not less than two thousand pesos nor more than five thousand pesos, or
imprisonment for not less than six months nor more than two years, or both, in the
discretion of the court:

(a) Any person who shall practice Medical Technology in the Philippines without being
registered or exempted from registration in accordance with the provisions of this Act;

(b) Any medical technologist, even if duly registered, who shall practice medical
technology in the Philippines without the necessary supervision, of a qualified
pathologist or physician authorized by the Department of Health;

(c) Any medical technologist who shall knowingly make a fraudulent laboratory report;

(d) Any duly registered medical technologist who shall refuse or fail, after due warning
by the Board to display his certificate of registration in the place where he works;

(e) Any person presenting or attempting to use as his own, the certificate of registration
of another;

(f) Any person who shall give any false or fraudulent evidence of any kind to the Board
or any member thereof in obtaining a certificate of registration as Medical Technologist ;

(g) Any person who shall impersonate any registrant of like or the same name;

(h) Any person who shall attempt to use a revoked or suspended certificate of
registration;

(i) Any person who shall in connection with his name or otherwise, assume, use or
advertise any title or description tending to convey the impression that he is a Medical
Technologist without holding a valid certificate of registration ;

(j) Any person who shall violate any provision of this Act; or

(k) Any person or corporate body who shall violate the rules and regulations of Board or
orders promulgated by it after having been duly approved and issued by the President
of the Philippines upon recommendation of the Commissioner of Civil Service for the
purpose of carrying out the provisions of this Act.
SEC. 30. Separability Clause.—If any provision of this Act or the application of such
provision to any person or circumstance is declared invalid by a court of competent
jurisdiction, the remainder of this Act or of the application of such provision to other
persons or circumstances shall not be affected by such declaration.

SEC. 31. Repealing Clause.—All Acts, executive orders, rules and regulations, or parts
thereof inconsistent with the provisions of this Act are hereby repealed: Provided,
however, That nothing in this Act shall be construed as repealing or amending any
portion of the Medical Act of 1959 (R.A. 2382, as amended by R.A. 4224), the Clinical
Laboratory Act of 1966 (R.A. 4688), and the Blood Banking Law of 1956 (R.A. 1517).
SEC 32. Effectivity.-This Act shall take effect upon its approval.

Approved, June 21, 1969.

 [ REPUBLIC ACT NO. 6138, August 31, 1970 ]

AN ACT TO AMEND CERTAIN SECTIONS OF REPUBLIC ACT NUMBERED FIVE

THOUSAND FIVE HUNDRED TWENTY-SEVEN, KNOWN AS THE PHILIPPINE
MEDICAL TECHNOLOGY ACT OF 1969.

Be it enacted by the Senate and House of Representatives of the Philippines in

Congress assembled:

SECTON 1. Sections sixteen, twenty-one, and twenty-two of Republic Act Numbered

Five thousand five hundred twenty-seven, known as the Philippine Medical Technology
Act of 1969, are hereby amended to read as follows:

"SEC. 16. Qualification for Examination.-Every applicant for examination under this Act,
shall, prior to the date thereof, furnish the Board satisfactory proof that he or she:

"(a) Is in good health and is of good moral character;

"(b) Has completed a course of at least four years leading to the degree of Bachelor of
Science in Medical Technology or Bachelor of Science in Hygiene conferred by a
recognized school, college or university in accordance with this Act or having graduated
from some other paramedical profession has been actually performing medical
technology for the last live years prior to the date of the examination, if such
performance began prior to the enactment of this Act."

"SEC. 21. Issuance of Certificate of Registration.-Every applicant who has satisfactorily

passed the required examination, shall be issued a certificate of registration as Medical
Technologist: Provided, That no such certificate shall be issued to any successful
applicant who has not attained the age twenty-one years. All certificates shall be signed
by all the members of the Board and attested by its Secretary. The duly registered
medical technologists shall be required to display his certificate of registration in place
where he works. Upon application filed after the approval of this Act not later than
ninety days after the Board shall have been fully constituted, the Board shall issue a
certificate of registration without examination persons who have been graduated with a
Bachelor of Science in Hygiene and/or Bachelor of Science in Medical Technology in
duly recognized schools of medical technology in the Philippines or foreign countries
who have been it the practice of medical technology, for at least three years prior to the
filing of the application, in laboratories in the Philippines or in foreign countries duly
accredited by the Bureau of Research and Laboratories, Department of Health, and also
to all other persons who having graduated from other paramedic profession are already
civil service eligible by authority of the other Boards of profession and who have been
actually performing medical technology practice for the last five years prior to the filing
of the application."
"SEC. 22. Fees.-The Board shall charge each applicant for examination and registration
the sum of fifty pesos, of which the sum of ten pesos shall be for registration, and for
each certificate of registration issued without prior examination in accordance with the
provisions of this Act the sum of twenty-five pesos; for issuance of a new certificate to
replace a certificate lost, destroyed or mutilated, the Board shall charge the sum of ten
pesos. All such fees shall be paid to the disbursing officer of the Civil Service
Commission who shall pay from the receipts there all authorized expenses of the Board
including the compensation of each member."

SEC. 2. This Act shall take effect retroactively as June 21, 1969.

Approved, August 31, 1970.

 [ PRESIDENTIAL DECREE NO. 498, June 28, 1974 ]

AMENDING SECTIONS TWO, THREE, FOUR, SEVEN, EIGHT, ELEVEN, THIRTEEN,

SIXTEEN, SEVENTEEN, TWENTY-ONE, AND TWENTY-NINE OF REPUBLIC ACT
NO. 5527, ALSO KNOWN AS THE PHILIPPINE MEDICAL TECHNOLOGY ACT OF
1969.

WHEREAS, Republic Act No. 5527, An Act Requiring: the Registration of Medical
Technologists, Denning Their Practice, And For Other Purposes took effect on June 21,
1969;
WHEREAS, in the implementation of said Act, some provisions were found to be
prejudicial to the interests of some medical technology practitioners who would
otherwise qualify for registration as medical technologist without examination; and
WHEREAS, it was likewise found that some provisions were inadequate to meet the
primary objectives of maintaining the high standard of the medical technology
profession, hence, there is an imperative need to correct these deficiencies of the said
Act.
NOW, THEREFORE, I, FERDINAND E. MARCOS, President of the Republic of the
Philippines, by virtue of the powers vested in me by the Constitution as Commander-in-
Chief of all the Armed Forces of the Philippines, and pursuant to Proclamation No. 1081
dated September 21, 1972, as amended do hereby order and decree:
SECTION 1. Subsections (a) and (d) of Section 2 of Republic Act No. 5527 are hereby
amended to read as follows:
"SEC. 2. Definition of Terms.—As used in this Act, the following terms shall mean:

a. Practice of Medical Technology.—A person shall be deemed to be in the practice

of medical technology within the meaning of this Act, who shall for a fee, salary
or other compensation or reward paid or given directly or indirectly through
another, renders any of the following professional services for the purpose of
aiding the physician in the diagnosis, study and treatment of diseases and in the
promotion of health in general:

1. Examination of tissues, secretions and excretions of the human body and body
fluids by various electronic, chemical, microscopic, bacteriologic, hematologic,
serologic, immunologic, nuclear, and other laboratory procedures and techniques
either manual or automated;
2. Blood banking procedures and techniques;
3. Parasitologic-Mycologic and Microbiologic procedures and techniques;
4. Histopathologic and Cytotechnology; provided that nothing in this paragraph shall
inhibit a duly registered medical laboratory technician from performing
histopathologic techniques and procedures.
5. Clinical research involving patients or human beings requiring the use of and/or
application of medical technology knowledge and procedures;
 6. Preparations and standardization of reagents, standards, stains and others,
provided such reagents, standards, stains and others are exclusively for the use
of their laboratory;
7. Clinical laboratory quality control;
8. Collection and preservation of specimens;

Provided, That any person who has passed the corresponding Board examination for
the practice of a profession already regulated by existing laws, shall not be subject to
the provisions of the last four (4) preceding paragraphs if the performance of such acts
or services is merely incidental to his profession.

d. Medical Laboratory Technicians.—A person certified and registered with the

Board as qualified to assist a medical technologist and/or qualified pathologist in
the practice of medical technology as defined in this Act."

SEC. 2. Section 3 of the same Act is hereby amended and now to read as follows:
"SEC. 3. Council of Medical Technology Education, Its Composition.—There is hereby
established a Council of Medical Technology Education, hereafter referred to as
Council, which shall be composed of the Commissioner of the Professional Regulation
Commission as Chairman, the Chairman of the Board of Medical Technology as Vice-
Chairman, and the two (2) members of the Board of Medical Technology, and the
Director of Private Education or its duly authorized representative, the Director of the
Bureau of Research and Laboratories of the Department of Health, and a representative
of the deans or heads of the private schools of medical technology, as member."
SEC. 3. Section 4 of the same Act is hereby amended to read as follows:
"SEC. 4. Compensation and Traveling Expenses of Council Members.—For every
meeting actually attended, the Chairman shall be entitled to a fifty pesos (P50.00) per
diem while the members shall be entitled to twenty-five pesos (P25.00) each regardless
of whether or not they receive regular salaries from the government. In addition, the
Chairman and members of the Council shall be entitled to traveling expenses in
connection with their official duties."
SEC. 4. Section 7 of the same Act is hereby amended to read as follows:
"SEC. 7. Medical Technology Board.—There is hereby created a Medical Technology
Board under the Professional Regulation Commission, which shall thereafter be referred
to as the Board composed of a Chairman who is a pathologist, and two (2) members
who are registered medical technologists who shall be appointed by the President of the
Republic of the Philippines upon recommendation of the Professional Regulation
Commission. The Chairman and members of the Board shall hold office for three (3)
years after appointment or until their successors shall have been appointed and duly
qualified: Provided, That the incumbent members will continue to serve until the
expiration of their terms.
In case of death, disability, or removal of a member of the Board, his successor shall
serve only the balance of his term."
SEC. 5. Paragraph 3 and 5 of Section 8 of the same Act are hereby amended to read
as follows:
"SEC. 8. Qualification of Examiners.—No person shall be appointed a member of the
Medical Technology Board unless he or she:

1. x x x
2. x x x x
3. is a duly registered medical technologist of the Philippines with the degree of
Bachelor of Science in Medical Technology/Bachelor of Science in
Hygiene/Public Health;
4. x x x
5. is not a member of the faculty of any medical technology school for at least two
(2) years prior to appointment or having any pecuniary interest direct or indirect
in such institution."

SEC. 6. Subsection (c) of Section 11 of the same Act is hereby amended and
subparagraphs (g), (h) and (1) are hereby added to read as follows:
"SEC. 11. x x x

c. (c) Issue, suspend and revoke certificates of registration for the practice of
medical technology and medical laboratory technician;

g. To determine the adequacy of the technical staff of all clinical laboratories and
blood banks before they could be licensed with the Department of Health in
accordance with R.A. No. 4355 and 1517;
h. To prescribe the qualification and training of medical technologists as to special
fields of the profession and supervise their specialty examination conducted by
the professional organization of medical technologists accredited by the
Professional Regulation Commission;
i. To classify and prescribe the qualification and training of the technical staff of
clinical laboratories as to: Chief Medical Technologist; Senior Medical
Technologist; Medical Technologist and Medical Laboratory Technician."

SEC. 7. Section 13 of the same Act is hereby amended to read as follows:

"SEC. 13. Accreditation of Schools of Medical Technology and of Training
Laboratories.—Upon the recommendation of the Medical Technology Board, the
Department of Education and Culture shall approve schools of medical technology in
accordance with the provisions of this Decree. The Professional Regulation
Commission upon recommendation of the Medical Technology Board shall approve
laboratories for accreditation as training laboratories for medical technology students or
post graduate trainees upon satisfactory evidence that said laboratories possess
qualified personnel and are properly equipped to carry out laboratory procedures
commonly required in the following fields: bacteriology, serology, parasitology,
hematology, biochemistry, and blood banking, and that the scope of activities of said
laboratory offer sufficient training in said laboratory procedures."
SEC. 8. Subparagraph (b) of Section 16 is hereby amended to read as follows:
"SEC. 16. x x x

b. Has completed a course of at least four (4) years leading to the degree of
Bachelor of Science in Medical Technology or Bachelor of Science in Public
Health conferred by a recognized school, college or university in accordance with
this Decree or having graduated from some other profession and has been
actually performing medical technology for the last five (5) years prior to the date
of the examinations, if such performance began prior to June 21, 1969."

SEC. 9. Section 17 of the same Act is hereby amended to read as follows:

"SEC. 17. Scope of Examination.—The examination questions shall cover the following
subjects with their respective relative weights:
Clinical Chemistry 20%
Microbiology & Parasitology 20%
Hematology 20%
Blood Banking & Serology 20%
Clinical Microscopy (Urinalysis and other
10%
body fluids)
Histopathologic Techniques, Cytotechnology,
Medical Technology Laws, Related Laws and
10%
its implementing rules, and the Code of
Ethics
The Board shall prepare the schedule of subjects for examination and to submit the
same to the Commissioner of the Professional Regulation Commission for publication at
least thirty (30) days before the date of examination. The Board shall compute the
general average of each examinee according to the above-mentioned relative weights
of each subject. Provided, however, That the Board may change, add to or remove the
list of subjects or weights above as progress in the science of Medical Technology may
require, subject to the prior approval of the Professional Regulation Commission, and
publication of the change or amendment at least three (3) months prior to the date of
examination in which the same is to take effect."
SEC. 10. Section 21 of the same Act is hereby amended to read as follows:
"SEC. 21. Issuance of Certificate of Registration.—Every applicant who has
satisfactorily passed the required examination for medical technologist shall be issued a
certificate of registration as such. Provided that no such certificate shall be issued to
any successful applicant who has not attained the age of twenty-one (21) years. All
certificate shall be signed by the members of the Board and by the Commissioner of the
Professional Regulation Commission. The duly registered medical technologists shall
be required to display his certificate of registration in the place where he
works: Provided, That upon application filed and the payment of the required fee of one
hundred and fifteen pesos (P115.00) the Board shall issue a certificate of registration as
medical technologist without examination to persons who have been graduated with
Bachelor of Science in Medical Technology/Bachelor of Science in Public Health in duly
recognized schools of medical technology in the Philippines or in any foreign country,
provided, that in case of the latter, the standard of medical technology education is
substantially the same as ours, and in addition shall have been in the practice of
medical technology for at least three (3) years prior to the filing of the application in
laboratories in the Philippines duly accredited by the Bureau of Research and
Laboratories, Department of Health, or in foreign countries if such performance began
prior to June 21, 1969 and also to all other persons who having graduated from other
professions have been actually performing medical technology practice for the last eight
(8) years prior to filing of the application: Provided, That such performance began prior
to June 21, 1969. Provided, further, That the Board shall likewise issue a certificate of
registration as medical laboratory technician without examination to any person who
upon application and payment of the required fee of fifty pesos (P50.00) show evidence
satisfactory to the Board that:

1. He or she passed the civil service examination for medical technician given on
March 21, 1964; or
2. Has finished a two-year college course and has at least one (1) year of
experience as medical laboratory technician: Provided, That for every year of
deficiency in college attainment two (2) years of experience may be
substituted: Provided, further, that an applicant who has at least ten (10) years
experience as medical laboratory technician as of the date of approval of this
Decree regardless of his academic attainment may qualify for registration without
examination; or
3. Has failed to pass the board examination for medical technology but had
obtained a general rating of at least 70%: Provided, finally, that a registered
medical laboratory technician when employed in the government shall have the
equivalent civil service eligibility not lower than second grade."

SEC. 11. Section 29 subparagraph (j) of the same Act is hereby amended to read as
follows:
"(j) Any person or corporate body who shall allow anyone in his employ who is not a
registered medical technologist medical laboratory technician to engage in the practice
of medical technology or recommend for appointment anyone to the position of medical
technologist/medical laboratory technician knowing that he is not registered as such."
SEC. 12. Repealing Clause.—All laws, executive orders, decrees, rules and regulations
or parts thereof, inconsistent with the provisions of this Decree are hereby repealed,
amended or modified accordingly.
SEC. 13. This Decree shall take effect immediately.
Done in the City of Manila, this 28th day of June, in the year of Our Lord, nineteen
hundred and seventy-four.

(Sgd.) FERDINAND E. MARCOS

 President of the
Philippines

By the President:

(Sgd.) ALEJANDRO MELCHOR

Executive Secretary
 [ PRESIDENTIAL DECREE NO. 1534, June 11, 1978 ]

FURTHER AMENDING REPUBLIC ACT NO. 5527 AS AMENDED BY PRESIDENTIAL

DECREE NO. 498 OTHERWISE KNOWN AS THE PHILIPPINE MEDICAL
TECHNOLOGY ACT OF 1969.

WHEREAS, Presidential Decree No. 498 amended certain sections of Republic Act No.
5527 otherwise known as the Philippine Medical Technology Act of 1969;
WHEREAS, in the implementation of said decree, certain sections thereof have been
found to hamper or render ineffective certain functions and duties of the Department of
Education and Culture and the Department of Health; and
WHEREAS, the aforesaid Decree contains provisions which prejudice the practice of
anatomic and clinical pathology by qualified physicians thus negating one of the primary
objectives of the original Medical Act of 1969;
NOW, THEREFORE, I, FERDINAND E. MARCOS, President of the Philippines, by
virtue of the powers vested in me by the Constitution, hereby order and decree:
SECTION 1. Section 3 of Republic Act No. 5527 as amended by Presidential Decree
No. 498 is hereby amended to read as follows:
“SEC. 3. Council of Medical Technology Education; Its Composition.—There is hereby
established a Council of Medical Technology Education hereafter referred to as the
Council, which shall be composed of the Director of Higher Education as Chairman; the
Chairman of the Professional Regulation Commission as Vice-Chairman; and the
Director of the Bureau of Research and Laboratories of the Department of Health, the
Chairman and two (2) members of the Board of Medical Technology, a representative of
the Deans of Schools of Medical Technology and Public Health, and the Presidents of
the Philippine Society of Pathologists and the Philippine Association of Medical
Technologists, as members.”
SEC. 2. Paragraph 3, Section 8 of Republic Act No. 5527 as amended is hereby
amended to read as follows:
“SEC. 8. Qualification of Examiners.—No person shall be appointed as a member of
the Medical Technology Board unless he or she: x x x is a qualified Pathologist, or a
duly registered Medical Technologist, of the Philippines with the degree of Bachelor of
Science in Medical Technology/Bachelor of Science in Hygiene/Public Health; x x x.”
SEC. 3. Subparagraphs (g) and (i) of Section 11 of Republic Act No. 5527 as amended,
are hereby repealed.
SEC. 4. Section 13 of Republic Act No. 5527 as amended, is hereby further amended to
read as follows:
“SEC. 13. Accreditation of Schools of Medical Technology and of Training
Laboratories.—The Department of Education and Culture shall approve schools of
Medical Technology in accordance with the provisions of this Act, as amended, in
conjunction with the Board of Medical Technology. The Department of Health through
the Bureau of Research and Laboratories shall approve laboratories for accreditation as
training laboratories for medical technology students or post-graduate trainees in
conjunction with the Board of Medical Technology. The laboratories shall show
satisfactory evidence that they possess qualified personnel and are properly equipped
to carry out laboratory procedures commonly required in the following fields: Clinical
Chemistry, Microbiology, Serology, Parasitology, Hematology, Blood Banking, Clinical
Microscopy, and Histopathologic techniques, and that the scope of activities of said
laboratories offer sufficient training in said laboratory procedures.”
SEC. 5. Section 12 of Presidential Decree No. 498 is hereby amended to read as
follows:
“SEC. 12. Repealing Clause.—All those Executive Order, Decrees, Rules and
Regulations, or parts thereof inconsistent with the provisions of this Decree are hereby
repealed, amended or modified accordingly: Provided, however, That nothing in this
Decree shall be construed as repealing or amending any portion of the Medical Act of
1959 (Republic Act No. 2382, as amended by Republic Act No. 4224), and the Clinical
Laboratory Act of 1966 (Republic Act No. 4688), and the Blood Banking Law of 1956
(Republic Act No. 1517), and the Rules and Regulations issued pursuant to these laws.”
SEC. 6. This Decree shall take effect immediately.
Done in the City of Manila, this 11th day of June, in the year of Our Lord, nineteen
hundred and seventy-eight.
(Sgd.) FERDINAND E. MARCOS
President of the Philippines

By the President:

(Sgd.) JACOBO C. CLAVE

Presidential Executive Assistant
 Republic of the Philippines
Professional Regulation Commission
Manila

PROFESSIONAL REGULATORY BOARD OF MEDICAL TECHNOLOGY

RESOLUTION NO. 72
Series of 2022

CODE OF ETHICS OF THE MEDICAL TECHNOLOGY PROFESSION

WHEREAS, Section 7 of Republic Act No. 5527, also known as “Philippine Medical
Technology Act of 1969”, as amended, created a Board of Examiners for Medical
Technology (Board);

WHEREAS, Section 11 thereof states that the Board is vested with authority to look
into conditions affecting the practice of medical technology in the Philippines and
whenever necessary, adopt such measures as may be deemed proper for the
maintenance of good ethics and standards in the practice of medical technology and
to draft such rules and regulations as may be necessary to carry out the provisions
of the law;

WHEREAS, the Code of Ethics was first published by the Philippine Association of
Medical Technologist (PAMET) in 1968 prior to the approval of R.A. No. 5527 in 1969.
It was then revised in 1997;

WHEREAS, in 2012 and 2014, a review of the Code of Ethics for Medical Technology
was conducted by the Board and while the contents were found to be comprehensive
enough, the Board still finds the need to elaborate on some statements and to include
other commitments to continuously improve the professional skills and knowledge of
the medical technologists;

WHEREAS, in 2018, the Board formed a Committee composed of representatives

from various key sectors like the academe, industry, and laboratory practitioners to
review the present Code of Ethics;

WHEREAS, in 2019, the Board, together with the Committee members, organized
the articles (Code) into its final draft. However, the onset of the global pandemic in
2020 resulted in the disruption and changes in priority in the work of the Board and
the Committee;

WHEREAS, on June 25, 2021, the Board and the Committee members resumed its
work towards the finalization of the Code for the Commission’s adoption and
approval;

NOW, THEREFORE, the Professional Regulatory Board of Medical Technology

(Board) RESOLVES to prescribe, promulgate and issue this CODE OF ETHICS OF
THE MEDICAL TECHNOLOGY PROFESSION:

PREAMBLE

This Code of Ethics is promulgated to provide the medical technologist with proper
ethical and professional standards in the practice of Medical Technology to ensure
the safety and welfare of patients. This Code sets forth the fundamental ethical
principles and the professional responsibilities of the medical technologist towards
patients, the healthcare system, the community, his/her colleagues, self, and the
profession, allied professionals and the health products industry. The medical
technologist shall cherish and take pride in his/her calling and conduct himself/herself
in accordance with this Code and the generally accepted principles of the
International Code of Medical Technology Ethics.
Resolution No. 72 (s 2022)
CODE OF ETHICS OF THE
MEDICAL TECHNOLOGY PROFESSION

ARTICLE I
GENERAL PRINCIPLES

Section 1. The primary objective of the practice of medical technology/medical

laboratory science is service to mankind, without bias to a patient’s or colleague’s
race, religion, gender, political belief or medical condition.

Section 2. A medical technologist shall commit to the highest degree of

professionalism, excellence, competence and integrity in the practice of the
profession.

Section 3. A medical technologist shall adhere to principles of quality and safe

practice.

Section 4. A medical technologist shall put the patients’ interest above his/her own.
A medical technologist shall perform his/her duties with competence and integrity
and shall maintain the confidentiality of all the patients’ information in accordance
with the existing legislation.

Section 5. A medical technologist shall be accountable and responsible for his/her

professional and personal conduct, and is expected to demonstrate good judgment
and behavior to ensure excellent laboratory performance for the best possible patient
care.

Section 6. A medical technologist shall contribute to the profession’s development

through lifelong learning such as self-development, mentorship, or collaboration with
institutions and accredited local, national and international organizations in medical
technology.

Section 7. A medical technologist shall maintain allegiance and a deep sense of civic
responsibility towards his/her community and country.

Section 8. A medical technologist shall treat other professionals with respect and
foster cooperation and collaboration among them.

Section 9. A medical technologist shall refrain from engaging in activities which may
give rise to conflict of interest.

ARTICLE II
RESPONSIBILITIES TO PATIENTS

Section 1. A medical technologist shall attend to patients faithfully, conscientiously

and timely and shall secure for them all possible benefits that may depend upon
professional skill and care. A medical technologist shall be polite, courteous,
attentive, reassuring and caring.

Section 2. A medical technologist shall dutifully perform his/her tasks, regardless of

the patient’s age, gender, creed, or nationality.

Section 3. A medical technologist shall seek appropriate assistance, according to

established protocols in situations beyond his/her knowledge and skills.

Section 4. A medical technologist shall keep all patient’s information and results
obtained with strict confidentiality, except when the disclosure is required by
pertinent laws, rules and regulations.

Section 5. A medical technologist shall only engage in lawful and appropriate

procedures that promote the best interest and safety of the patient.
Resolution No. 72 (s 2022)
CODE OF ETHICS OF THE
MEDICAL TECHNOLOGY PROFESSION

ARTICLE III
RESPONSIBILITIES
TO SELF AND TO THE PROFESSION

Section 1. A medical technologist shall personify professionalism, integrity,

responsibility, accountability and competence in the conduct of his/her professional
as well as personal life.

Section 2. A medical technologist shall continuously update and upgrade knowledge

and skills in the practice of the profession brought about by modernization as well as
scientific and technical advancements in the profession.

Section 3. A medical technologist shall ensure compliance with the medical

technology law, other related laws and regulatory policies affecting the practice of
the profession.

Section 4. A medical technologist is duty-bound to report to the proper authorities

illegal acts and other violations in the practice of the profession, including illegal
practice, for the protection of the public.

Section 5. A medical technologist shall actively support and apply principles, policies
and guidelines for the protection of the environment, especially in biosafety and
biosecurity practices.

Section 6. A medical technologist shall ensure compliance with Quality Assurance

Program following the standards of Good Laboratory Practice.

Section 7. A medical technologist shall endeavor to engage in community or social

work where their services are needed, such as but not limited to cases of emergency,
disaster or other similar circumstances.

Section 9. A medical technologist shall fulfill the duties and responsibilities as a

member of the accredited professional organization through active participation in
continuing professional development and other activities and to respect the
constitution and by-laws of the organization.

Section 10. The medical technologist shall accept reasonable professional fees on
matters relative to research, consultancy, and activities that require his/ her
expertise in the field of medical laboratory science and/or allied sciences.

Section 11. A medical technologist shall accept, carry-out and discharge the
responsibilities inherent to being a professional. He/she shall uphold the dignity of
the profession by imbibing the virtues of reliability, honesty and integrity.

ARTICLE IV
RESPONSIBILITIES
TO COLLEAGUES AND OTHER PROFESSIONALS

Section 1. A medical technologist shall establish cooperative, honest and respectful

working relationships with other medical technologists.

Section 2. A medical technologist shall act in the spirit of fairness and maintain a
culture of fellowship with the members of the medical technology and other
professions.

Section 3. A medical technologist shall maintain harmonious working relationships

with other professionals of different interdisciplinary practice and respect the scopes
and limitations of their practice vis-à-vis the other professions.
Resolution No. 72 (s 2022)
CODE OF ETHICS OF THE
MEDICAL TECHNOLOGY PROFESSION

ARTICLE V
PROFESSIONAL RELATIONSHIP WITH
THE HEALTH PRODUCT INDUSTRY (HPI)

Section 1. A medical technologist shall collaborate with HPI for the advancement of
medical technology and the quality of healthcare services.

Section 2. A medical technologist shall foster a relationship that encourages the

development of a healthcare professional practice that is committed to patients' well-
being and is based on truthful, accurate, and updated scientific evidence.

Section 3. A medical technologist shall interact with HPI to meet the highest ethical
standards, preserve independent decision-making and uphold public confidence in
the integrity of patient care and product and service selection.

Section 4. A medical technologist shall collaborate with HPI within the bounds of
applicable laws and codes of conduct for the best interest of the patients.

Section 5. A medical technologist shall collaborate with HPI for professional

advancement on new technologies and equipment through educational and
experiential training.

Article VI
PENAL PROVISIONS

Pursuant to the power of the Board to issue, suspend and revoke Certificates of
Registration for the practice of medical technology, violation of any section of the
Code of Ethics shall constitute unethical and unprofessional conduct, and shall
therefore be a sufficient ground to reprimand, suspend, or revoke the Certificate of
Registration of the offending medical technologist in accordance with the provisions
of RA No. 5527, as amended, and Republic Act No. 8981 (PRC Modernization Act of
2000).

Article VII
AMENDMENTS

Amendments to the Code of Ethics may be initiated by the Board, in consultation with
the Accredited Professional Organization (APO) and other stakeholders. The final
proposed amendments shall be submitted for approval by the Board to the
Commission.

Article VIII
EFFECTIVITY

This Code of Ethics shall take effect after fifteen (15) days following its publication in
the Official Gazette or in any newspaper of general circulation.

Let copies hereof be furnished the UP Law Center and the APO for the Medical
Technology profession.

Done in the City of Pasay, this 13th day of September, 2022.

Resolution No. 72 (s 2022)
CODE OF ETHICS OF THE
MEDICAL TECHNOLOGY PROFESSION

ATTESTED:

APPROVED:

VACANT
Chairperson

JOSE Y. CUETO, JR. ERWIN M. ENAD

Acting Chairperson Commissioner

DATE OF PUBLICATION IN THE

PHILIPPINE STAR : Sept. 16, 2022
DATE OF EFFECTIVITY : Oct. 02, 2022
Resolution No. 72 (s 2022)
CODE OF ETHICS OF THE
MEDICAL TECHNOLOGY PROFESSION

Annex 1

Revised Code of Ethics

As I enter the practice of Medical Technology, I shall:

 Accept the responsibilities inherent to being a professional

 Uphold the dignity and respect of my profession and conduct myself a reputation
of reliability, honesty, and integrity

 Perform my task with full confidence reliability and accuracy.

 Treat any information I acquired about individuals in the course of my work as

strictly confidential

 Commit myself to continuously improve my professional skills and

knowledge

 Share my knowledge and expertise to my colleagues

 Contribute to the advancement of the professional organization and other allied

health organizations

 Act in a spirit of fairness to all and a spirit of brotherhood to other members of the
profession

 Restrict my praises, criticisms, views, opinions within constructive limits

 Accept employment from more than one employer only when there is no conflict
of interest

 Be dedicated to the use of Clinical laboratory science to promote life and benefit
mankind

 Uphold the law and shall not engage in illegal work

 Report any violation of the above principles of professional conduct to the

authorized agency and the ethics committee of the organization.

To these principles, I hereby subscribe and pledge to conduct myself at all times in a
manner befitting the dignity of my profession.
FIFTEENTH CONGRESS OF THE )
REPUBLIC OF THE PHILIPPINES )
First Regular Session )
'11 FEB 28 P4 :32
SENA.:r:E.
S.B. No. i:: '12 2

Introduced by Senator EDGARDO J. ANGARA )7

EXPLANATORY NOTE

The Philippines is globally recognized as a soUrce of the world's medical professionals

such as doctors, nurses, physical therapists and medical technologists. As early as 1960, the
Philippines has been educating medical technologists for the world health industry who are
scientifically and technologically equipped to deliver the full spectrum of Medical Teclmology
services required in modem health care.

Medical technologists from the Philippines are in high demand, thus their training
education should be at par with the rest of the world's medical professionals. Philippine schools
that offer Medical Technology courses have taken steps to adjust and amend their curriculum in
response to advances and current trends in the medical 'Vorld.

Republic Act 5527, otherwise known as The Medical Technology Act, was enacted in
1969. The law has become obsolete and no longer responds to the current practice of medical
technology education. '

This bill seeks to create an Board of Medical Technology under the Professional
Regulation Commission (PRC). The said Board will be headed by a qualified medical
teclmologist. A Technical Panel in Medical Technology Education under the Commission on
Higher Education shall also be created. Further, this bill seeks to introduce Continuing Medical
Teclmology Education and Certification of Phlebotomists.

Through this bill, it is hoped that medical teclmology education in the Philippines will
improve, enabling its graduates to become globally competitive and highly skilled. Hence, the
passage of this bill is earnestly sought.

h/~
EDGARDO J. ANGARA
•
 CONGRESS OF THE PHILIPPINES )
FIFTEENTH CONGRESS )
First Regular Session )
'11 FEB 28 P4 :32
SENATE

Senate Bill No. 2722

Introduced by Senator Edgardo J. Angara

AN ACT REGULATING AND MODERNIZING THE PRACTICE OF MEDICAL

TECHNOLOGY (MEDICAL LABORATORY SCIENCE) IN THE PHILIPPINES,
REPEALING, FOR THIS PURPOSE, REPUBLIC ACT NOS. 5572 AND 6132 AND
PRESIDENTIAL DECREE NOS. 498 AND 1534, AND FOR OTHER PURPOSES

Be it enacted by the Senate and the House of Representatives in Congress assembled:

•

SECTION 1. Title. - This act shall be known as the "Medical Technology Act of2011."
2
.
3 SECTION 2. Declaration of Policy. - The State recognizes the importance of the
4 Medical Technology profession in nation building and development through the portals of
,
5 healthcare, education and research. Hence, it shall dt<velop and nurture competent, virtuous,
6 productive and well-rounded medical technologists whose standard of practice and service shall
'.
7 be world class.
8
9 Further, the State shall promote, regulate and protect the professional practice of Medical
10 Technology in the Philippines and shall ensure its continued growth and development and the
II maintenance of high international standards of practice. ,
12
13 SECTION 3. Definition of Terms. - As used in this Act, the following terms shall mean:
14
15 a. Accredited Medical Technology Training Laboratory - Refers to a
16 clinical laboratory duly licensed by the Department of Health and accredited as a
17 training laboratory by the Commission on Higher Education upon
18 recommendation by the Technical Panel in Medical Technology Education or its
19 equivalent.
20
21 b. Accredited Professional Organization - Refers to a national
22 organization, recognized and accredited by the Board, as approved by the
23 Professional Regulation Commission, under which all registered medical

I
 technologists whose names appear in the roster of Medical Technologists of the
2 Professional Regulation Commission automatically become members.
3
4 c. Board - Refers to the Board: of Medical Technology of the
5 Professional Regulation Commission.
6
7 d. Continuing Medical Technology Education (CMTE) - Refers to
8 the enhancement of knowledge, professional competence and ethical values in the
9 practice of medical technology through mandatory formal classes or training
,
10 programs administered for medical technologists.
11
12 e. Code of Professional Ethics - Refers to a set of standards relating
13 to the conduct, integrity and moral duties of medical technolo gists as prescribed
14 and promulgated by the duly accredited professional organization of medical
15 technologists, with the approval of the Board.
16
17 f. Hearing Committee - Refers to a body composed of two (2)
18 Members of the Board and one (1) legal officer. The Hearing Committee shaH
19 conduct administrative proceedings for the suspension or revocation of a
20 certificate of registration.
21
22 g. Medical Technology (MediC'll Lal;Joratory Science) - Refers to the
23 healthcare profession that performs laboratory investigations on the human body
24 or on specImens talcen from the human body, the results of which provide
25 information used by physicians or other medical practitioners in relation to
26 healthcare, research, forensics and other related areas.
27
28 Medical Technology may also refer to laboratory investigations on
29 animals in relation to veterinary medicine and agricultural purposes.
30
31 h. Medical Technologist - Refers to a holder of a Bachelor of Science
32 Degree in Medical Technology (Medical Labordtory Science) or Public Health
33 who is duly registered with the Professional Regulation Commission and is
34 qualified to practice Medical Technology.
35
36 A person shall be deemed to be in the practice of Medical Technology
37 within the meaning of this act if such person renders any of the following services
38 for a fee, salary, compensation or reward paid or given directly or indirectly:
39

2
 "

1 1. Examination of tissues, secretions and excretions of the human

2 body and other bodily fluids through electronic, chemical,
3 microscopic, microbiologic, hematologic, serologic,
•
4 immunologic, nuclear, molecular, cytogenetic or other
5 laboratory procedures and techniques, either manual or
6 automated;
7 2. Blood banking procedures and techniques or other blood
8 transfusion services;
9 3. Parasitologic, Bacteriologic, Mycologic, Virologic or other
10 microbiologic techniques;
11 4. Histopathologic or Cytotechnologic techniques;
12 5. Drug Testing in clinical laboratories;'
13 6. Research involving human beings or animals requiring the use
14 of or application of Medical Technology (Medical Laboratory
15 Science) knowledge and procedures;
16 7. Preparations and standardization of reagents, standards, stains
17 or others. Provided, that such reagents, standards, stains or
18 others are exclusively for the use of tlie laboratory;
19 8. Clinical laboratory quality control;
20 9. Phlebotomy, collection, processing or preservation of
21 specImens;
22 10. Consultancy 111 test upgrading, method selection, laboratory
23 equipment planning and troubleshoot!ng where the application
24 of knowledge in medical technology i~ required;
25 11. Teaching of professional subjects in Medical Technology;
26 12. Introduction, demonstration, evaluation, or improvement of
27 clinical laboratory procedures or techniques; and
28 13. Similar activities to the foregoing where the training, skill and
29 experience of a medical technologist, are needed as may be
30 determined under the rules and regulations to be promulgated
31 by the Professional Regulation Commission.
32
33 1. Medical Laboratory Technician - Refers to a person certified and
34 registered with the Board as qualified to assist a medical technologist in the
35 practice of Medical Technology as defined under Republic Act No. 5527. The
36 Board shall discontinue the registration of medical
. , laboratory technicians under
37 Republic Act No. 5527 upon the effectivity of this Act. Provided, that Medical
38 laboratory technicians registered under Republic Act No. 5527 shall maintain

3
 their status as registered medical laboratory te~hnicians. Provided, further, that a
2 registered medical technologist occupying the position of a medical laboratory
3 technician shall be rendered an appropriate position and be reclassified as a
4 medical technologist.
5
6 j. Phlebotomist - Refers to a holder of a Bachelor of Science Degree
•
7 in Medical Technology (Medical Laboratory Science) and who has passed an
,
8 examination for Phlebotomy given by the Board of Medical Technology of the
,
9 Professional Regulation Commission. Provided, that a registered medical
10 technologist automatically qualifies as a Phlebot~mist.
11
12 A Phlebotomist is qualified to perform ,blood specimen collection and to
13 follow proper procedures of identification,. preservation and transport of
<,
14 specimens.
15
16 k. Recognized School of Medical Technology - Refers to any school,
17 college or university which offers a program in Medical Technology (Medical
18 Laboratory Science) approved by the Commissipn on Higher Education upon the
19 recommendation of the Technical Panel in Medical Technology Education or its
20 equivalent.
21
22 1. Technical Panel in Medical Techllology Education - Refers to the
23 Technical Panel in Medical Technology Education reconstituted or organized
24 under the Office of Programs and Standards of the Commission on Higher
25 Education,
26
27 SECTION 4. Board of Medical Technology. ,- There IS hereby created a Board of
28 Medical Technology under the Professional Regulation Commission. The Board shall be
29 composed of a Chairman and two (2) members, all of whom are registered medical technologists,
30 The Chairman and the Members of the Board shall be appointed by the President of the Republic
31 ofthe Philippines ("President") upon recommendation of the Philippine Regulation Commission
32 and shall serve for a term of three (3) years. The Chairman and the Members of the Board shall
33 hold such office until their successors shall have been <;lppointed and duly qualified. Provided,
34 That the incumbent Chairman and Members of the Board shall continue to serve their terms until
"
35 the expiration of the same.
36
37 For its recommendation, the Philippine Regulation Commission shall submit to the
•
38 President a list containing at least three (3) names for the appointment of the Chairman or any

4 <,
 •
1 Member of the Board at least thirty (30) days prior to ,the expiration of the term of the Chairman
2 or any Member of the Board.
3
'.

4 In case of death, disability or removal for cause of the Chairman or any Member of the
5 Board, his successor shall only serve the balance ofhis.ferm.
6
7 SECTION 5. Qualifications of the Chairman ard the Members of the Board. - No person
8 shall be appointed as Chairman or as a Member of the Board unless he is a Filipino Citizen, of
9 good moral character and is a duly registered medical technologist. Provided, that the Chairman
10 and the Members of the Board must be members in good standing in their respective accredited
11 national professional organization. Provided, further, that the Chairman and the Members of the
12 Board must not be an officer or a director of their respective accredited national professional
13 organization at any time during their appointment.
14
15 The Chairman mnst have a Masters Degree and should have at least fifteen (J 5) years of
16 experience as a medical technologist, including at I~ast ten (10) years of clinical laboratory
17 practice. He must be actively practicing his profession as a medical technologist at least five (5)
18 years prior to his appointment.
19
20 A Member of the Board must have at least ten (10) years of experience as a medical
21 technologist, including at least five (5) years of c1inicaJ laboratory practice. He must be actively
22 practicing his profession as a medical technologist, at least three (3) years prior to his
23 appointment.
24
25 The Chairperson and the Members of the Board shall not, in any way, be professionally
26 connected with the faculty of any Medical Technology school or review center for at least three
27 (3) years prior t6 their appointment. Further, they shall have no pecuniary interest, directly or
28 indirectly, in any such institution at any time during their appointment.
'.
29
30 SECTION 6. Compensation of the Members of the Board. - The Chairman and each
31 Member of the Board shall receive compensation in such amount as the Professional Regulation
32 Commission may determine. Provided, that such compensation shall be competitive with the
33 compensation of other professional boards of the Professional Regulation Commission.
34
35 SECTION 7. Functions and Duties of the Board. - The following are duties and
36 functions of the Board:
37
38 a. Administer and implement the provisions of this Act;

5
 b. Determine and prepare the questions for the licensure examination for medical
2 technologists;
3 c. Regulate the practice of the profession ',in accordance with professional
4 regulatory law;
5 d. Administer oaths in connection with the administration of this Act;
6 e. Issue, suspend or revoke certificates of registration of medical laboratory
7 technicians;
8 f. Look into conditions affecting the practice of medical technology in the
9 Philippines and, whenever necessary, adopt such measures as may be deemed
10 proper for the maintenance of good ethic~ and standards in the practice of
II medical technology;
12 g. Investigate violations of this Act or of '~he rules and regulations issued
13 hereunder. For this purpose, the Board may issue subpoenas and subpoenas
14 duces tecum;
15 h. Draft such rules and regulations as may be necessary to carry out the
•
16 provisions of this Act;
17 i. Prescribe the qualifications and training of medical technologists with regard
"
18 to special fields of the profession and to supervise their special examination to
19 be conducted by the professional organization of medical technologists
20 accredited by the Professional Regulation Commission;
21 J Formulate and recommend the approval of refresher courses for applicants
22 who fail to pass the Board Examinations for ,the third time;
23 k. Determine and prepare the questions for the certification examination of
24 Phlebotomists; and
25 I. Such other functions as may be prescribed by the Professional Regulation
26 Commission, in accordance with existing laws governing the Commission.
27
28 SECTION 8. Removal of the Board Members. - The Chairman or any Member of the
29 Board may be removed by the President for neglect" of duty, incompetence, malpractice or
30 unprofessional, unethical, immoral or dishonorable, conduct after having been given an
31 opportunity to defend himself in a proper administrative proceeding. Provided, that pending the
32 resolution ofthe administrative proceeding, the President shall have the power to indefinitely
33 suspend the Chairman or any Member of the Board under investigation and appoint a temporary
34 member in his place.
35
36 SECTION 9. Licensure Examinations. - Except~,as otherwise specifically allowed under
37 the provisions of this Act, all applicants for registration as medical technologists shall be

6
 1 required to undergo a written examination which sh\!11 be given by the Board semi-annually
2 during tbe months of May and November in such places
, as the Board may deem proper.
3
4 The examination for Phlebotomy Certification shall be given by the Board annually
•
5 during the month of September in such places as the Board may deem proper.
6
"
7 SECTION 10. Qualifications for Admission to the Licensure Examination. - Every
8 applicant for examination under this Act shall, at least thirty (30) days ,prior to the date of the
9 examination, furnish the Board satisfactory proof that he:
10
11 a. Is in good health and is of good moral character;
12 b. Is a holder of a Bachelor of Science Degree in Medical Technology (Medical Science
13 Technology) or Public Health from a recognized school, college or university.
14 Provided, that a holder of a Bachelor of Science Degree in Public Health should have
15 complied with the standards as stipulated in the Policies, Standards and Guidelines
16 for Medical Technology education;
17 c. Has paid the required examination fees as may be determined by the Professional
18 Regulation Commission; and
19 d. Has complied with other requirements that ,the Board of the Professional Regulation
20 Commission may prescribe.
21
22 SECTION II. Scope of Examination. - The examination questions shall cover the
23 following subjects and shall be accorded the respective weights:
24
Clinical Chemistry 20%
Microbiology & Parasitology 20%
Hematology 20%
Blood Banking, Immunohematology, Immunology & Serology 20%
,
Clinical Microscopy (Urinalysis and Other Bodily Fluids) 10%
Histopathologic and Cytologic Techniques, Laboratory Management, Medical 10%
Technology Law, Related Laws and their implementin~ Rules and the Code of Ethics
25
26 The Board shall prepare the schedule of subjects' for examination and submit the same to
27 the Commissioner of the Professional Regulation Commission for publication. The Board shall
28 compute the general average of each examinee according to the above-mentioned relative
29 weights of each subject. Provided, that the Board may change, add to and remove from the list of
30 subjects or weights above as progress in the science of Medical Technology may require.
31 Provided, further, that any change, addition, removal or modification of the subjects or weights
32 shall be subject to the prior approval of the Professional Regulation Commission.

7
 1
2 SECTION 12. Report of Rating. - The Board shall, after the date of completion of the
.,
3 examination, report the result thereof for the approval, of the Commissioner of the Professional
4 Regulation Commission within the time limit and guidelines set by the Professional Regulation
5 Commission.
6
7 SECTION 13. Ratings in the Examination. '-- In order to pass the examination, a
8 candidate must obtain a general average of at least sev~nty-five percent (75%) in the written test,
9 with no rating below fifty percent (50%) in any of the' subjects. An applicant who has failed the
10 examinations in at least three (3) attempts shall not be qualified to take further examinations until
11 such applicant shall have completed a refresher course in accordance with the rules prescribed by
12 the Board.
13
14 SECTION 14. Oath Taking. - All successful, examinees shall be'required to take a
15 professional oath before the Board prior to entering upon the practice of medical technology in
16 the Philippines.
17
18 SECTION 15. Issuance of Certificate of Registration. Every applicant who has
19 satisfactorily passed the req~ired examination for J1l.edical teclmologists shall be issued a
20 certificate of registration. All certificates shall be signed by the Chairman and the Members of
21 the Board and by the Commissioner of the Professi,onal Regulation Commission. The duly
22 registered medical teclmologist shall be required to display his certificate of registration and
23 Professional Regulation Commission identification card in the place where he works.
24
25 The Board shall refuse to issue a certificate of registration to any person convicted by a
26 court of competent jurisdiction of any criminal offens!: involving moral turpitUde, or who has
27 committed immoral, dishonorable or dishonest conduct, or is of unsound mind, or is suffering
28 from an incurable and communicable disease. In the event of the Board's refusal to issue a
29 certificate of registration, it shall issue a written statement
, to the applicant, setting forth
. the
30 reason for its action. The statement issued by the Board shall be incorporated in its records.
31
32 SECTION 16. Fees. - The fees to be paid by each applicant for the issuance of a new
, "
33 certificate of registration, for the replacement of a lost, destroyed or mutilated certificate of
34 registration, or for the issuance or replacement Of Professional Regnlation Commission
35 identification cards shall be in accordance with the fees established by the Professional
36 Regulation Commission.
37

8
 1 SECTION 17. Revocation or Suspension of Certificates of Registration. - The revocation
2 or suspension of a certificate of registration may only be made after the completion of an
3 administrative proceeding conducted by the hearing ',committee composed of at least two (2)
4 members of the Board and one (1) legal officer. Provided,
, that the existing rules of evidence
5 shall be observed during the administrative proceeding~ Provided, further, that the person whose
6 certificate of registration is sought to be revoked or suspended shall be entitled to be represented
7 by counsel, to have a speedy, impartial and public proceeding, to confront the witnesses against
8 him and to all other rights guaranteed by the Constituti(il11,
9
•
10 The Board may, after giving proper notice and .hearing to the party concerned, reprimand
II an erring medical technologist, revoke or suspend his certificate of registration for violating any
12 provision of this Act, any rules or regulations issued pursuant to this Act or for unprofessional
13 conduct, malpractice, incompetency, gross ignorance or gross negligence in the practice of
14 medical technology.
15
16 The hearing committee may, by a majority vote, Impose the penalty of revocation,
17 suspension or reprimand. Provided, that the suspension of the certificate of registration shall not
18 exceed two (2) years,
19
20 When the penalty of suspension or revocation is imposed by the hearing committee the
21 medical technologist shall be required to surrender his ~ertificate of registration within thirty (30)
22 days after the decision becomes final. Should a medical technologist fail to surrender his
23 certificate of registration within the said period, the Board may disqualify him perpetually from
24 the practice of medical technology. The suspension shall run from the date of such surrender.
25
26 SECTION 18, Appeal - The revocation or suspension of a certificate of registration
27 made by the hearing committee may be appealed primarily and exclusively to the Professional
28 Regulation Commission. The decision of the Professional Regulation Commission may be
•
29 elevated to the Court of Appeals in accordance with the'Rules of Court.
30
31 SECTION 19, Reissuance or Reinstatement of a revoked or suspended Certificate of
32 Registration, - The Board may reissue a revoked certificate of registration upon the application
33 of the medical technologist whose certificate of registration was revoked. Provided, that the
34 reissuance of a revoked certificate of registration may' only be made for proper and sufficient
35 reasons, Provided, further, that no revoked certificate of, registration may be reissued within one
36 (1) year from the date it was surrendered by the medical technologist whose certificate of
37 registration was revoked.
38

9
 "

I The suspension of a certificate of registration shall be automatically lifted upon the

2 expiration of the period of suspension. Said certificate of registration shall be reinstated to the
3 medical technologist concerned upon request.
4
5 The reissuance or reinstatement of the certificate of registration shall be without prejudice
6 to further actions by the Board for a violation of any provision of this Act, its implementing rules
7 or regulations or any condition imposed by the Board ,upon the medical technologist q.uring the
8 period of revocation or suspension.
9
10 SECTION 20. Roster of Medical Technologist.
, , - A roster of Medical Technologist shall
11 be prepared annually by the Secretary of the Board. This roster shall contain the name, address
12 and citizenship of each registered medical technologist; the date of registration or issuance of the
13 certificate of registration and any other pertinent data. The roster shall be open to public
14 inspection, and copies thereof shall be placed on file in the Professional Regulation Commission,
15 and furnished to other offices, private or governmental and to the public, upon request.
16
17 SECTION 21. Medical Technology (Medical Laboratory Science) Education. - The Medical
18 Technology (Medical Laboratory Science) course shall'·be at least four years, as stipulated in 111e
19 Commission on Higher Education's Policies, Standar~s and Guidelines. Said course shall be
20 composed of general education, core and professional courses, and a satisfactory internship
21 program in accredited training laboratories. It shall include the following professional subjects;
22
23 a. Hematology;
24 b. Clinical Chemistry;
25 c. Microbiology; "
26 d. Parasitology;
27 e. Blood Banking/Immunohematology;
28 f. Serology/Innnunology;
29 g. Clinical Microscopy;
30 h. Histopathology & Cytology;
31 i. Laboratory Management; and
32 J. Medical Technology Laws & Ethics
33
34 The Technical Panel in Medical Technology Education ("TPMTE") is hereby authorized
35 to change, remove from or add to the subjects listed, subject to the approval of the Commission
36 on Higher Education.
37

10
 1 SECTION 22. Creation and Composition of'Technical Panel in Medical Technology
2 Education (I'PMTE). - There is hereby established a Technical Panel in Medical Technology
3 Education under the Commission on Higher Education - Office of Programs and Standards
4 (CHED-OPS). The TPMTE shall be composed of the following members:
5
6 a. The President of the Philippine Association of Schools of Medical
•
7 Technology and Hygiene (PASMETH), who shall be the Chairman;
,
8 b. The President of the Philippine Association of Medical Technologists, Inc.
9 (PAMET);
10 c. A representative from the Board of Medical Technology/ Professional
11 Regulation Commission;
12 d. A representative from PAMET; and
13 e. A representative from PASMETH
14 '.
15 The TPMTE shall be supported by a secretariat aud staff.
16
17 SECTION 23. Functions of TPMTE. - The TPMTE shall assist the Commission on
18 Higher Education in setting Policies, Standards and Guidelines for the Medical Technology
19 Program. It may also assist in its implementation, including monitoring and evaluation.
20
21 The functions of the TPMTE are as follows:
22
23 a. To recommend the minimum curriculum required for the course of medical
24 technology;
25 b. To determine and prescribe the number of stu!ients that will be allowed to take
26 the medical technology course in each school, taking into account the student-
27 instructor ratio and the availability offacilities for instruction;
28 c. To recommend the closure of medical technology schools which are found to
29 be substaudard;
30 d. To require all medical technology schools to submit au annual report,
. 31 including the total number of students and instructors, a list of facilities
32 ,
available for instruction, a list of their recent graduates aud new
33 administrations, on or before the month of JUlle;
34 e. To inspect, whenever necessary, the differerrt medical technology schools in
"
35 the country in order to determine whether a high standard of education is
36 maintained in said instructions;
37 f. To promulgate, prescribe aud enforce such rules and regulations as may be
38 necessary for the proper implementation of th~ foregoing functions.

11 '.
 1
2 SECTION 24. Accreditation of Schools of, Medical Technology and of Training
3 Laboratories. - The Commission on Higher Education, through TPMTE, shall approve schools
4 of Medical Technology and accredit laboratories for training of students in accordance with the
5 provisions of this Act. The laboratories shall show. satisfactory evidence that they possess
6 qualified personnel and are properly equipped to carry out laboratory procedures commonly
7 required in the folloWing fields: Clinical Chemistry, Microbiology, Serology, Parasitology,
•
8 Hematology, Blood Banking, Clinical Microscopy, and Histopathologic Techniques, and that the
9 scope of activities of said laboratories offer sufficient training in said laboratory procedures.
10
11 SECTION 25. Studies for Medical Technology Manpower Needs, Production,
12 Utilization and Development. - The Board, in coordination with the accredited professional
13 organization and appropriate government and private agencies shall initiate, undertake and
14 conduct studies on health, human resources production, ',utilization and development.
15
16 SECTION 26. Accredited Professional Organization. - All registered medical
17 technologists whose names appear in the roster of the Professional Regulation Commission shall
18 automatically become members of a national, accredited professional organization of registered
19 and licensed medical technologists. For this purpose, the Board shall only recognize and accredit
20 one national organization for registered and licensed medical technologists, subject to the
21 approval by the Professional Regulation Commission. Members of the said accredited
!
22 professional organization shall receive benefits and privileges appurtenant thereto upon payment
23 of the required fees and dues. Membership in the accredited professional organization shall not
24 be a bar to membership in any other association of allied' health professionals.
25
26 SECTION 27. Continuing Medical Technology Education (CMTE). - There shall be a
27 program of Continuing Medical Technology Educati~~ (CMTE) conducted by the accredited
28 professional organization and other CMTE providers to,enhance and maintain the proficiency of
,
29 its members on current medical technology procedures and techniques.
30
31 All Registered medical technologists shall abide by the requirements, rules and
32 regulations on CMTE which shall be promulgated by the Board, subject to the approval of the
33 Professional Regulation Commission. For this purpose, a CMTE Council is hereby created to
•
34 implement the CMTE Program.
35
36 SECTION 28. Medical Technology Training and Education Program. - Upon the
37 effectivity of this Act, the Board in coordination with 'the accredited professional organization
38 shall develop training and education programs in order to upgrade the level of skill and

12
 competence of medical technologists. A medical technologist shall be required (0 uudergo a
2 medical technology training and education program every three (3) years beginning from the
3 issuance of his certificate of registration.
4
5 SECTION 29. Salary. - In order to enhance ~e general welfare, commitment (0 service
6 and professionalism of medical technologists, the minimum base pay of a registered medical
7 technologist should not be lower than an amouut equivalent to Salary Grade 15 under Republic
8 Act No. 6758 or the "Compensation and Classification Act of 1989".
9
10 SECTION 30. Foreign Reciprocity - No foreipner shall be admitted to an examination,
11 be given a certificate of registration or be entitled to an¥ of the rights or privileges under this Act
12 unless the couutry or state of which he is a subje~t or a citizen permits Filipino medical
13 technologists to practice within its territorial limits on the same basis as the subjects or citizens
14 of said couutry or state.
15
•
16 SECTION 31. Inhibition Against the Practice \If Medical Technology. - No person shall
17 practice or offer to practice medical technology as defililed in this Act without having previously
18 obtained a valid certificate of registration from the·• Board. Provided, that a certificate of
19 registration shall not be required from the following:
20
21 a. Duly registered physicians;
22 b. Medical technologists from other countriyS called for consultation or as
23 visiting or exchange professors to colleges or universities: Provided, That
24 their practice of medical technology within the couutry is limited to their
25 performance of the said function; and
26 c. Medical technologists in the service of the Armed Forces of the United States
27 of America who are stationed in the Philippines and are rendering services as
28 such for members of the said armed forces only.
29
30 SECTION 32. Penal Provisions. - Without prejudice to the provisions of the Medical
31 Act of 1959, as amended, relating to the illegal practice of medicine, the following shall be
32 punished by a fine of not less than two thousand pesos (P2,000.00) nor more than five thousand
33 pesos (P5,000.00), or imprisonment for not less than six (6) months nor more than two (2) years,
34 or both, in the discretion of the court:
35
36 a. Any person who. shall practice Medical Techpology in the Philippines without
37 being registered or exempted from registration in accordance with the
38 provisions of this Act;

13
 1 b. Any medical technologist who shall knowl~gly make a fraudulent laboratory
2 report;
3 c. Any person presenting or attempting. to use as his own, the certificate of
4 registration of another;
5 d. Any person who shall give any false or fraudulent evidence of any kind to the
6 Board or any member thereof in obtaining a certificate of registration as a
'.
7 medical technologist;
8 e. Any person who shall impersonate any registrant;
9 f. Any person who shall attempt to use a revoked or suspended certificate of
10 registration;
11 g. Any person who shall, in connection with Ijis name or otherwise, assume, use
12 or advertise any title or description tending to convey the impression that he is
13 a medical technologist without holding a valid certificate of registration;
14 h. Any person or corporate body who shall allow a non-registered medical
15 technologist/medicallaboratory technician under his employment to engage in
16 the practice of medical technology or recommend the appointment of anyone
17 to the position of a medical technologistlmedicallaboratory technician while
18 knowing that he is not registered as such;
19 i. Any person or corporate body who shall violate any provision of this Act or
20 any rules or regulations issued pursuant to this Act.
21
22 SECTION 33. Enforcement of this Act. - It shall be the primary duty of the Professional
23 Regulation Commission and the Board to effectively implement this Act. Any law enforcement
24 agency and officers, employees and agents of national, provincial, city or municipal governments
25 shall, upon the call or request of the Professional Regl,llation Commission or the Board, render
26 assistance in enforcing the provisions of this Act and, to prosecute any persons violating the
27 same.
28
29 SECTION 34. Appropriations. - The Chairperson of the Professional Regulation
30 Commission shall include in the Commission's program the funding requirements for the
•
31 implementation of this Act. Thereafter, the amount necessary for the continued implementation
32 of this Act shall be included in the General Appropriations Act.
'.
33
34 SECTION 35. Rules and Regulations. Within ninety (90) days after the effectivity of this
35 Act, the Board and the Professional Regulation Commission, in coordination with the accredited
36 professional organization, the Department of Health, the Department of Budget and Management
37 and other concerned agencies, shall formulate such rules and regulations necessary to carry out

14
 1 the provisions of this Act. The implementing rules and regulations shall be published in the
2 Official Gazette or in any newspaper of general circulation.
3
4 SECTION 36. Separability Clause - Should any provision herein be declared
5 unconstitutional, the same shall not affect the validity of the other provisions of this Act.
6
7 SECTION 37. Repealing Clause - Republic Act Nos. 5572 and 6132, Presidential Decree
8 Nos. 498 and 1534. and all other laws, presidential decrees, executive orders, ruJes and
9 regulations inconsistent with the provisions of this Act'are hereby repealed, amended or modified
10 accordingly .
.11
12 SECTION 38. Effectivity - This Act takes effect fifteen (15) days after its publication in
13 at least two (2) newspapers of general circulation.
14
15 Approved,

'.

15
 CLINICAL
LABORATORY
LAWS
 [ REPUBLIC ACT NO. 4688, June 18, 1966 ]

AN ACT REGULATING THE OPERATION AND MAINTENANCE OF

CLINICAL LABORATORIES AND REQUIRING THE REGISTRATION OF
THE SAME WITH THE DEPARTMENT OF HEALTH, PROVIDING
PENALTY FOR THE VIOLATION THEREOF, AND FOR OTHER
PURPOSES.

Be it enacted by the Senate and House of Representatives of the

Philippines in Congress assembled:

SECTION 1. Any person, firm or corporation, operating and maintaining a

clinical laboratory in which body fluids, tissues, secretions, excretions and
radioactivity from beings or animals are analyzed for the determination of
the presence of pathologic organisms, processes and/or conditions in the
persons or animals from which they were obtained, shall register and
secure a license annually at the office of the Secretary of
Health: Provided, That government hospital laboratories doing routine or
minimum laboratory examinations shall be exempt from the provisions of
this section if their services are extensions of government regional or
central laboratories.

SEC. 2. It shall be unlawful for any person to be professionally in-charge of

a registered clinical laboratory unless he is a licensed physician duly
qualified in laboratory medicine and authorized by the Secretary of Health,
such authorization to be renewed annually.

No license shall be granted or renewed by the Secretary of Health for the

operation and maintenance of a clinical laboratory unless such laboratory is
under the administration, direction and supervision of an authorized
physician as provided for in the preceding paragraph.

SEC. 3. The Secretary of Health, through the Bureau of Research and

Laboratories shall be charged with the responsibility of strictly enforcing
the provisions of this Act and shall be authorized to issue such rules and
regulations as may be necessary to carry out its provisions.

SEC. 4. Any person, firm or corporation who violates any provisions of this
Act or the rules and regulations issued thereunder by the Secretary of
Health shall be punished with imprisonment for not less than one month
but not more than one year, or by a fine of not less than one thousand pesos
nor more than five thousand pesos, or both such fine and imprisonment, at
the discretion of the court.

SEC. 5. If any section or part of this Act shall be adjudged by any court of
competent jurisdiction to be invalid, the judgment shall not affect, impair,
or invalidate the remainder thereof.

SEC. 6. The sum of fifty thousand pesos, or so much thereof as may be

necessary, is hereby authorized to be appropriated, out of any funds in the
National Treasury not otherwise appropriated, to carry into effect the
provisions of this Act.

SEC. 7. All Acts or parts of Acts which are inconsistent with the provisions
of this Act are hereby repealed.

SEC. 8. This Act shall take effect upon its approval.

Approved, June 18, 1966.

 Republic of the Philippines
Department of Health
OFFICE OF THE SECRETARY
2/F Building 1, San Lazaro Compound, Rizal Avenue, Sta. Cruz, 1003 Manila
Trunk Line 743-83-01 Direct Line: 711-9501; Fax: 743-1829;743-1829; 743-1786
URL: http://www.doh.gov.ph; e-mail: osec@doh.gov.ph

August 22, 2007

ADMINISTRATIVE ORDER
No. 2001 - oot.l

SUBJECT: Revised Rules and Regulations Governing the Licensure and

Regulation of Clinical Laboratories in the Philippines

I. RATIONALE

One of the main thrusts of current health sector reforms under FOURmula One (F1) for
Health is regulation. The main objective of regulatory reforms is to ensure access to quality
and affordable health products, devices, facilities and services, especially those commonly
used by the poor.

Physicians utilize laboratory work-ups in aid of diagnosis and management of patients.

Accuracy of laboratory results is important in assuring and improving the quality of patient
care. Republic Act No. 4688 s. 1966, "An Act Regulating the Operation and Maintenance of
Clinical Laboratories and Requiring the Registration of the Same with the Department of
Health, Providing Penalty for the Violation Thereof, and for Other Purposes", mandated the
DOH to look after public welfare by effectively enforcing and updating the current regulations
to improve laboratory performance.

Advances in technology necessitate the need to update the minimum standards and
technical requirements for clinical laboratories. Current regulatory issuances on this matter
may no longer be relevant. One of these is Administrative Order No. 59 s. 2001, entitled:
"Rules and Regulations Governing the Establishment, Operation and Maintenance of
Clinical Laboratories in the Philippines". Thus, this Order revises such issuance in order to
ensure the quality of services of clinical laboratories nationwide.

II. OBJECTIVE

This Order is promulgated to prescribe a revised m1n1mum standard for clinical

laboratories. This shall also ensure accuracy and precision of laboratory examinations in
order to safeguard public health and safety.

Ill. SCOPE AND COVERAGE

This Administrative Order shall apply to all individuals, agencies, partnerships or

corporations that operate clinical laboratories in the Philippines performing examination and
analysis of samples of tissues, fluids, secretions, excretions, or other materials from the
human body that would yield relevant laboratory information, which physicians use for the
prevention, diagnosis, and treatment of diseases, and the management and promotion of
personal and public health.

Government clinical laboratories, doing microscopy work only for specific DOH programs
such as but not limited to malaria screening, acid fast bacilli microscopy, tests for sexually

Page1of10
transmitted infections, and cervical cancer screening using Pap smears, shall be exempted
from the provisions of this Order.

IV. DEFINITION OF TERMS

For purposes of this Order, the following terms and acronyms shall have the following
definition:

1. Applicant - a natural or juridical person who intends to operate a clinical

laboratory
2. BHFS- acronym for the Bureau of Health Facilities and Services
3. CHD- acronym for the Center for Health Development
4.- Clinical Laboratory - a facility where tests are done on specimens from the
human body to obtain information about the health status of a patient for the
prevention, diagnosis and treatment of diseases. These tests include, but are
not limited to, the following disciplines: clinical chemistry, hematology,
immunohematology, microbiology, immunology, clinical microscopy,
histopathology, cytology, toxicology, endocrinology, molecular biology, and
cytogenetics. Other functions of the clinical laboratory are to provide consultative
advisory services covering all aspects of laboratory investigation including the
interpretation of results and advice on further appropriate investigation. Facilities
that are involved in the pre-analytical processes, such as the collection, handling
or preparation of specimens, or act as a mailing or distribution center, such as in
a laboratory network or system are also considered to be a part of a clinical
laboratory. The total testing process includes pre-analytical, analytical and post-
analytical procedures.
5. Critical Values - panic values originally described by Lundberg as "life-
threatening" unless something is done promptly and for which some corrective
action could be undertaken.
6. DOH- acronym for the Department of Health
7. EQAP- acronym for External Quality Assessment Program. It is a program where
participating laboratories are given unknown samples for analysis. These
samples are to be treated as ordinary human specimens for the usual
processing and examination. The quality of performance of the laboratory shall
be assessed through the closeness of its results to the pre-determined value or
to the reference value generated by the participating laboratories through peer
group analysis.
8. Inspection Tool- the checklist used by the regulatory officers during inspection
visit(s) to evaluate compliance of a clinical laboratory to the minimum standards
and technical requirements.
9. Institution - a corporate body or establishment organized for an educational,
medical, charitable, or similar purpose.
10. License- the document issued by the DOH to an individual, agency, partnership
or corporation that operates a clinical laboratory upon compliance with the
requirements set forth in this Order.
11. Licensee - the individual, agency, partnership or corporation to whom the
license is issued and upon whom rests compliance with this Order.
12. L TO - acronym for License to Operate. It also refers to the license
13. Mobile Clinical Laboratory- a laboratory testing unit that moves from testing site
to another testing site, or has a temporary testing location. It shall have a base
laboratory.
14. Monitoring Examinations - tests done in series on patients as a guide for
treatment or follow-up of their condition.
15. NRL - acronym for the National Reference Laboratory. It is a laboratory in a
government hospital which had been designated by the DOH to provide special
functions and services for specific disease areas. These functions include

Page 2 of 10
 provision of referral services such as confirmatory testing, surveillance,
resolution of conflicting results between or among laboratories; training;
research, implementation of EQAS; evaluation of diagnostic kits and reagents.
An NRL may or may not be part of a general clinical laboratory.
16. POL - acronym for Physician's Office Laboratory. It is an individual doctor's
office/ clinic wherein laboratory examinations are performed.
17. POCT- acronym for Point of Care Testing. It is a diagnostic testing at or near
the site of patient care rather than in the clinical laboratory. It includes bedside
testing, outpatient and home care.
18. Routine Tests - the basic, commonly requested tests in the laboratory, the
results of which are not required to be released immediately upon completion. It
shall follow the usual procedures and system in the laboratory.
19. Satellite Testing Site - any testing site that performs laboratory examinations
under the administrative control of a licensed laboratory, but performed outside
the physical confines of that laboratory.
20. STAT Tests- tests done on urgent cases, the results of which shall be released
immediately, within one (1) hour after the procedure. STAT is an abbreviation
for sta'tim which means immediately.

V. CLASSIFICATION OF CLINICAL LABORATORIES

A. Classification by Ownership
1. Government - operated and maintained, partially or wholly, by the national
government, a local government unit (provincial, city or municipal), any other
political unit or any department, division, board or agency thereof
2. Private - owned, established and operated by any individual, corporation,
association or organization

B. Classification by Function
1. Clinical Pathology includes Clinical Chemistry, Hematology,
Immunohematology, Microbiology, Immunology, Clinical Microscopy,
Endocrinology, Molecular Biology, Cytogenetics, Toxicology and Therapeutic
Drug Monitoring and other similar disciplines
2. Anatomic Pathology - includes Surgical Pathology, lmmunohistopathology,
Cytology, Autopsy, Forensic Pathology and Molecular Pathology

C. Classification by Institutional Character

1. Institution Based - a laboratory that operates within the premises and as part of
an institution, such as but not limited to hospital, medical clinic, school, medical
facility for overseas workers and seafarers, birthing home, psychiatric facility,
drug rehabilitation center
2. Freestanding - a laboratory that does not form part of any other institution

D. Classification by Service Capability

1. General Clinical Laboratory
(a) Primary Category- provides the following minimum service capabilities:
i. Routine Hematology [Complete Blood Count- includes Hemoglobin Mass
Concentration, Erythrocyte Volume Fraction (Hematocrit), Leucocyte
Number Concentration (White Blood Cell or WBC Count) and Leucocyte
Type Number Fraction (Differential Count)
ii. Qualitative Platelet Determination
iii. Routine Urinalysis
iv. Routine Fecalysis
v. Blood Typing -for hospital based

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 (b)Secondary Category- provides the minimum service capabilities of a primary
category laboratory plus the following:
i. Routine Clinical Chemistry - includes Blood Glucose Substance
Concentration, Blood Urea Nitrogen Concentration, Blood Uric Acid
Substance Concentration, Blood Creatinine Concentration, Blood Total
Cholesterol Concentration
ii. Quantitative Platelet Determination
iii. Cross Matching -for hospital based
iv. Gram Staining -for hospital based
v. KOH -for hospital based

(c) Tertiary Category- provides the minimum' service capabilities of a secondary

category laboratory plus the following:
i. Special Chemistry
ii. Special Hematology, including coagulation procedures
iii. Immunology
iv. Microbiology- culture and sensitivity
• aerobic and anaerobic (for hospital based)
• aerobic or anaerobic (for non-hospital based)

A clinical laboratory, licensed under any of the above category, shall be

permitted to offer laboratory services other than the respective stipulated
minimum services, provided that, they comply with the requirements with respect
to staff, equipment, reagents and supplies for such additional services, provided
further, that such additional services are listed under its LTO.

(d) Limited Service Capability (for institution-based only) - provides the

laboratory tests required for a particular service in institutions such as but not
limited to dialysis centers and social hygiene clinics.

2. Special Clinical Laboratory

A laboratory that offers highly specialized laboratory services that are usually
not provided by a general clinical laboratory.

VI. GUIDELINES

A. GENERAL GUIDELINES
1. The LTO shall be issued only to clinical laboratories that comply with the
standards and technical requirements formulated by the BHFS.
2. Clinical laboratories that are operated and maintained exclusively for research
and teaching purposes shall be exempted from the licensing requirement of this
Order but shall be required to register with the BHFS.
3. Special clinical laboratories that are not subject to the provisions of other
administrative orders, such as but not limited to, Assisted Reproduction
Technology Laboratories, Molecular and Cellular Technology, Molecular Biology,
Molecular Pathology, Forensic Pathology, Anatomic Pathology laboratories
operating independent of a clinical laboratory are required to register with the
BHFS without being licensed under the provisions of this Order. Such procedure
shall subsist until the appropriate regulation for such purpose is subsequently
promulgated. A pathologist or a licensed physician who is trained in the
management, principles and methodology of the specialized services that are
being provided shall head this type of laboratory.
4. The NRL designated by the DOH shall be covered by the license of the clinical
laboratory of the hospital where they are respectively assigned. The NRL that is
physically independent from the clinical laboratory of the hospital where they are
respectively assigned shall be allowed to register only with the BHFS, provided

Page 4 of 10
 that, they are duly accredited or certified by an international accrediting or
certifying body, such as but not limited to, the Center for Disease Control of the
U.S.A and the World Health Organization and/ or local accrediting or certifying
body recognized by the DOH.
5. A POL is required to secure a clinical laboratory license when it undertakes any
or all of the following activities:
(a) Issue official laboratory results;
(b) Perform more than monitoring examinations; and,
(c) Cater not only to the physician's own patients.
Examinations performed in a POL shall only be permitted when they are used for
monitoring patients.
6. A POCT, conducted in a hospital, is required to be under the management and
supervision of the licensed clinical laboratory of the respective hospital.

B. SPECIFIC GUIDELINES
1. Standards
Every clinical laboratory shall be organized to provide quality, effective and
efficient laboratory services.

(a) Human Resource

i. Every clinical laboratory shall be headed and managed by a pathologist,
certified either as a Clinical Pathologist, an Anatomic Pathologist, or both
by the Philippine Board of Pathology.
ii. The head of the laboratory shall have administrative and technical
supervision of the activities in the laboratory.
iii. The head of the laboratory shall supervise the staff in accordance to the
standards set by the Philippine Society of Pathologists.
iv. There shall be an adequate number of medical technologists and other
health professionals with documented training and experience to conduct
the laboratory procedures. The number of staff shall depend on the
workload and the services being provided.
v. There shall be staff development and continuing education program at all
levels of organization to upgrade the knowledge, attitude and skills of
staff.

(b) Equipment
i. There shall be available and operational equipment to provide the
laboratory examinations that the laboratory is licensed for.
ii. There shall be a calibration, preventive maintenance and repair program
for the equipment.
iii. There shall be a contingency plan in case of equipment breakdown.

(c) Glassware, Reagents and Supplies

i. There shall be available reagents, glassware and supplies for the
laboratory examinations to be provided.
ii. There shall be an inventory control of the reagents, glassware and
supplies.
iii. The reagents, glassware and supplies shall be stored under the required
conditions.

(d) Administrative Policies and Procedures - The clinical laboratory shall have
written policies and procedures for the provision of laboratory services and
for the operation and maintenance of the laboratory.

Page 5 of 10
(e) Technical Procedures -There shall be documented technical procedures for
services provided in each Section of the laboratory, which will ensure the
quality of laboratory results.

(f) Quality Assurance Program

i. There shall be an Internal Quality Assurance Program which shall include:
a) An Internal Quality Control Program for technical procedures
b) An Internal Quality Assurance Program for inputs, processes and
outputs
c) A Continuous Quality Improvement Program covering all aspects of
laboratory performance.
ii. The clinical laboratory shall participate in an EQAP administered by
designated NRL or in other local and international EQAP approved by the
DOH.

(g) Communication and Records

i. There shall be procedures for the receipt and performance of routine and
STAT requests for laboratory examinations.
ii. There shall be procedures for the reporting of results of routine and STAT
laboratory examinations, including critical values that would impact on
patient care.
iii. All laboratory reports on various examinations of specimens shall bear the
name and facsimile signature of the pathologist who shall be accountable
for the reliability of the results. The reports shall also bear the name and
signature of the registered medical technologist(s) who have performed
the examinations. Electronic signatures shall be permitted in accordance
to the provisions of theE-Commerce Law.
iv. There shall be procedures for the reporting of workload, quality control,
inventory control, work schedule and assignments.
v. There shall be procedures for the reporting and analysis of incidents,
adverse events, and in handling complaints.
vi. The retention of laboratory records shall be in accordance to the
standards promulgated by the DOH or by competent authorities for such
purposes.

(h) Physical Facilities/ Work Environment

i. The clinical laboratory shall conform to all applicable local and national
regulations for the construction, renovation, maintenance and repair of
clinical laboratories.
ii. The laboratory shall conform to the required space for the conduct of its
activities.
iii. There shall be well-ventilated, lighted, clean, safe and functional areas
based on the services provided.
iv. There shall be a program of proper maintenance and monitoring of
physical plant and facilities.
v. There shall be procedures for the proper disposal of waste and hazardous
substances.
vi. There shall be policy guidelines on laboratory biosafety and biosecurity.

(i) Referral of Examinations Outside of the Clinical Laboratory - When

laboratory examinations are referred to and provided by an outside
laboratory, the head of the referring clinical laboratory shall obtain assurance
of the quality of services provided through a Memorandum of Agreement or
its equivalent with a licensed clinical laboratory performing the laboratory
services needed.

Page 6 of 10
 2. LTO
(a) The LTO is issued in the name of the licensee and is non-transferable,
whether voluntarily or involuntarily, through sale, assignment or any other
means. The license is not valid for any premise/ location other than that
which is stipulated therein.
(b) The LTO issued to a clinical laboratory, unless sooner suspended or
revoked, is valid for one year and expires on the date set forth by the CHD,
as stipulated on the face of the license.
(c) The LTO issued to a non-hospital based clinical laboratory shall specifically
stipulate the following: name of the clinical laboratory, name/s of the owner
or operator, head of the laboratory, service capability, period of validity,
license number, and, location wherein the laboratory procedures are to be
performed.
(d) The LTO issued to a non-hospital based clinical laboratory must be
displayed at all times at a prominent place within the laboratory premises.
(e) Hospital based clinical laboratories shall be licensed as part of the hospital
through the One-Stop-Shop Licensure for Hospitals and are therefore not
required to obtain a separate license.
(f) The capability to perform HIV testing and/ or drinking water analysis shall be
specifically indicated in the LTO, as issued by the CHD.
(g) The clinical laboratory and its satellite services within the same compound
shall have one (1) LTO.
(h) A satellite laboratory outside the premises where the central laboratory is
situated shall be required to secure a separate LTO.
(i) Mobile clinical laboratories shall be licensed as part of the main clinical
laboratory and shall be permitted to collect specimens only. It shall be
allowed to operate only within one hundred (100) km radius from its main
laboratory.
U) Changes that would substantially affect the conditions of a clinical laboratory,
as set forth in its LTO, shall be reported to the concerned CHD within two (2)
weeks from the initial date of implementation. The report shall be in writing,
signed by the licensee, and submitted to the concerned CHD for notation.
(k) The LTO maybe revoked, suspended or modified in full or in part for any
material false statement by the applicant, or as shown by the record of
inspection or for a violation of, or failure to comply with any of the terms and
conditions and provisions of these rules and regulations.

VII. PROCEDURAL GUIDELINES

A. Registration for Special Clinical Laboratories, National Reference Laboratories,

Research and Teaching Laboratories
1. Applicants can acquire the prescribed Application Form for Registration from the
BHFS, CHD that has jurisdiction over the existing or proposed clinical laboratory,
or at the DOH website (www.doh.gov.ph).
2. The accomplished form together with the necessary attachments is to be
submitted to the BHFS or through the CHD that has jurisdiction over the existing
or proposed clinical laboratory. The applicant shall be required to pay a non-
refundable application fee for Certificate of Registration upon submission of the
accomplished form and documentary requirements.
3. The BHFS shall evaluate and accept applications based on due execution of
forms and completeness of attachments.

B. Procedures for Application for Initial/Renewal of LTO

1. Applicants can acquire the prescribed application form for LTO from the BHFS,
CHD that has jurisdiction over the existing or proposed clinical laboratory, or at
the DOH website (www.doh.gov.ph).

Page 7 of 10
 2. The accomplished form together with the necessary attachments is to be
submitted to the CHD that has jurisdiction over the existing or proposed clinical
laboratory. The applicant shall be required to pay a non-refundable application
fee for LTO upon submission of the accomplished form.
3. The CHD that has jurisdiction over the existing or proposed clinical laboratory
shall conduct inspections in accordance with licensing requirements, as provided
for under this Order and the One-Stop-Shop Licensure System for Hospitals.

C. Renewal of LTO
1. Renewal of hospital based clinical laboratories shall be in accordance with the
licensing process under the One-Stop-Shop Licensure System for Hospitals.
2. Non-hospital based clinical laboratories shall file applications for renewal of LTO
beginning on the first day of October until the last day of November of the current
year. A discount on the renewal fee shall be granted if a complete application is
filed during this period.
3. Renewal of license for compliant clinical laboratories shall be processed not later
than five (5) working days after the expiration date of its license.
4. The LTO of a clinical laboratory shall be automatically cancelled without notice
when it fails to submit a duly accomplished application form and to pay the proper
fee on or before the expiration date stated in its license.

D. Inspection
1. The CHD shall conduct an announced licensure inspections at any reasonable
time.
2. The licensee shall ensure the accessibility of the premises and facilities where
the laboratory examinations are being performed for the inspection of the CHD
Director or his authorized representative(s) at any reasonable time.
3. The licensee shall ensure the availability of all pertinent records for checking/
review of the CHD Director or his authorized representative(s).
4. An inspection tool, which prescribes the standards, criteria and technical
requirements for the issuance of LTO, shall be utilized.

E. Monitoring
1. All clinical laboratories shall be monitored regularly.
2. The BHFS or the CHD Director or his authorized representative(s) shall monitor
clinical laboratories through monitoring visits to the laboratory at any reasonable
time.
3. All c;,linical laboratories shall ensure that all laboratory records, premises and
facilities are made available to the BHFS or the CHD Director or his authorized
representative(s) in order to determine compliance with the provisions of this
Order.
4. A Notice of Violation for non-compliant clinical laboratories shall be issued
immediately after monitoring the clinical laboratory.
5. The CHD concerned shall submit a quarterly summary of the violations to the
BHFS stating the name of the clinical laboratory, location, its corresponding
violation and the course of action taken.
6. The Provincial, City and Municipal Health Officers are enjoined to report to the
BHFS/ CHD the existence of unlicensed clinical laboratories or any private party
performing laboratory examinations without proper license and/ or violations to
these rules and regulations.

VIII. SCHEDULE OF FEES

(a) A non-refundable fee shall be charged for the initial application/ renewal of
license to operate a clinical laboratory, either government or private.

Page 8 of 10
 (b) All fees/ checks shall be paid to the order of DOH in person or through postal
money order.
(c) All fees, surcharges and discounts shall follow the current DOH prescribed
schedule of fees.

IX. VIOLATIONS

Violation of Republic Act 4688 or these rules and regulations and/ or commission of the
following acts by personnel operating the clinical laboratory under this authority shall be
penalized:

(a) Refusal of any clinical laboratory to participate in an EQAP conducted by the

designated NRL or other external proficiency program approved by the DOH;
(b) Issuance of a report, orally or in writing, in whole or portions thereof, which is
not in accordance with the documented procedure approved by the head of the
laboratory;
(c) Permitting unauthorized persons to perform technical procedures;
(d) Demonstrating incompetence or making consistent errors in the performance of
clinical laboratory examinations and procedures;
(e) Deviation from the standard test procedures including use of expired reagents;
(f) Reporting/ release of erroneous results;
(g) Lending or using the name of the licensed clinical laboratory or the head of the
laboratory or medical technologist to an unlicensed clinical laboratory;
(h) Unauthorized use of the name and signature of the pathologist and medical
technologist to secure LTO;
(i) Reporting a test result for a clinical specimen even if the test was not actually
performed;
U) Transferring of results of tests done in an outside clinical laboratory to the result
form of the referring laboratory;
(k) Performing and reporting tests in a specialty or subspecialty in which the
laboratory is not licensed;
(I) Giving and receiving any commission, bonus, kickback or rebate or engaging in
any split-fee arrangement in any form whatsoever with any facility, physician,
organization, agency or person, either directly or indirectly, for patients referred
to a clinical laboratory licensed by the DOH.

X. INVESTIGATION OF COMPLAINTS

(a) The BHFS or the CHD Director or his authorized representative(s) shall
investigate the complaint and verify if the laboratory concerned or any of its
personnel is accountable for an alleged violation.
(b) The CHD Director or his authorized representative(s), after investigation, shall
suspend, cancel or revoke for a determined period of time the LTO of licensees
who are found violating the provisions of R.A. 4688 or this Order, without
prejudice to taking the case to judicial authority for criminal action. The CHD
shall seek the assistance of any law enforcement agency to execute the
closure of any erring clinical laboratory, when necessary.

XI. PENALTY

Any person who operates a clinical laboratory without the proper license from the DOH
shall upon conviction be subject to imprisonment for not less than one (1) month or a fine of
not less than Php 1,000.00 and not more than Php 5,000.00 or both at the discretion of the
court. Provided however, that if the offender is a firm or corporation, the managing head
and/ or owner(s) thereof shall be liable to the penalty imposed herein.

Page 9 of 10
XII. APPEAL

The decision of the BHFS/CHD may be appealed to the Office of the Health Secretary
within ten (1 0) days after receipt of the notice of the decision. Thereupon, the BHFS shall
promptly certify and file a copy of the decision, including all documents and transcript of
hearings on which the decision is based, with the Office of the Health Secretary for review.
The decision of the Office of the Health Secretary is final and executory.

XIII. REPEALING CLAUSE

Provisions from previous issuances that are inconsistent or contrary to the provisions of
this Order are hereby rescinded and modified accordingly.

XIV. SEPARABILITY CLAUSE

In the event that any provision or part of this Order be declared unauthorized or
rendered invalid by any court of law or competent authority, those provisions not affected by
such declaration shall remain valid and effective.

XV. EFFECTIVITY

This Order shall take effect fifteen ( 15) days after its approval and publication in the
official gazette or newspaper of general circulation.

Page 10 of 10
 Republic of the Philippines
Department of Health
OFFICE OF THE SECRETARY

JUN 11 200

ADMINISTRATIVE ORDER
No. 2021 -_ D037

SUBJECT: New Rules and Regulations Governing the Regulation of Clinical

Laboratories in the Philippines

RATIONALE

By virtue of Republic Act No. 4688 s. 1966, “An Act Regulating the Operation and
Maintenance of Clinical Laboratories and Requiring the Registration of the Same with the
Department of Health, Providing Penalty forthe Violation Thereof,and for Other Purposes,”
the Department of Health (DOH) through the Bureau of Medical Services, now known as
the Health Facilities and Services Regulatory Bureau (HFSRB), was mandated to ensure
public health, safety and welfare through enforcement of the Act and was authorized to issue
such rules and regulations as may be necessary to carry out the law. Clinical laboratory
services play an importantrole in the diagnosis, treatment, prevention and control of disease.
Thus, it is imperative that the laboratories generate accurate, precise and reliable laboratory
test results in a timely manner to
aid the physicians in
assuring the quality of patient care.

Through the years, several laboratory technological advancements have been introduced. As
such, certain provisions in the current Administrative Order (AO) No. 2007-0027, dated
August 22, 2007, titled “Revised Rules and Regulations Governing the Licensure and
Regulation of Clinical Laboratories in the Philippines,” may have become outdated. This
policy is being issued to align the laboratory procedures with the requirements of AO 2020-
0047 titled “Rules and Regulations Governing the Licensure of Primary Care Facilities in
the Philippines.”

The necessity to review the current AO and to revise and update the minimum standards and
technical requirements for licensing clinical laboratories in the Philippines is aligned with
the main objective of Republic Act No. 11223 or the Universal Health Care Act which is to
guarantee access to quality and affordable health products, devices, facilities and services.

IL. OBJECTIVE

These rules and regulations shall serve as the new guidelines in the licensing of diagnostic
clinical laboratories in the Philippines which shall ensure accountability of the laboratory on
generation of accurate, precise and reliable laboratory results in a timely manner through
continuous compliance.

Building 1, San Lazaro Compound, Rizal Avenue, Sta. Cruz, 1003 Manila e Trunk Line 651-7800 local 1108, 1111, 1112, 1113
Direct Line: 711-9502; 711-9503 Fax: 743-1829 @ URL: http://www.doh.gov.ph; e-mail: ftduque@doh.gov.ph
III. SCOPE OF APPLICATION

This Order shall apply to all individuals, agencies, partnerships or corporations, whether
private or government-owned, involved in the application for DOH license to operate and
those in the operation of diagnostic clinical laboratories in the Philippines.

This Order shall also apply to the Bangsamoro Autonomous Region in Muslim Mindanao
(BARMM) subject to the applicable provisions of RA 11054 or the “Bangsamoro Organic
Act” and subsequent rules and policies issued by the Bangsamoro Government.

Iv. DEFINITION OF TERMS

A. Applicant — refers to any natural juridical person, government

instrumentalities/agencies, partnership, corporation or agency seeking a license to
operate and maintain a clinical laboratory.

Assessment Tool — the checklist which prescribes the minimum standards and
requirements for licensure of a clinical laboratory.

Clinical Laboratory (CL) — a facility that is involved in the (a) pre-analytical, (b)
analytical, (c) and post-analytical procedures, where tests are done on specimens from
the human body to obtain information about the health status of a patient for the
prevention, diagnosis and treatment of diseases. These tests include, but are not limited
to, the following disciplines: anatomic pathology, clinical chemistry, clinical
microscopy, endocrinology, hematology, immunology and serology, microbiology,
toxicology, as well as molecular and nuclear diagnostics.

Department of Health - License to Operate (DOH-LTO) — a formal authorization issued

by the DOH to an individual, partnership, corporation, association or any government
agency/unit seeking to perform laboratory tests in compliance with the requirements
prescribed in this Order.

Department of Health - Permit to Construct (DOH-PTC) — a permit issued by DOH

through HFSRB or Center for Health Development-Regulation, Licensing and
Enforcement Division (CHD-RLED) to an applicant who will establish and operate a
hospital or other health facility, upon compliance with required documents prior to the
actual construction of the said facility. A DOH-PTC is also required for hospitals and
other health facilities with substantial alteration, expansion, renovation, increase in the
number of beds, transfer of site, or for additional services (add-ons) beyond their service
capability. It is a prerequisite for License to Operate.

External Quality Assessment Program (EQAP) — a program where participating CL are

given unknown samples for analysis. These samples should be treated as ordinary
human specimens for the usual processing and examination. The quality of performance
of the CL shall be assessed through the closeness of itsresults to the pre-determined
value or reference value generated by the participating CL through peer group analysis.

Initial Application — refer to applications by newly constructed health facilities, or those

with changes in the circumstances of the facility, such as, but not limited to, change of
ownership, transfer of site, increase in beds or for additional services beyond their
service capability and major alterations or renovations. Wf
I 2
 Mobile Clinical Laboratory (MCL) — a laboratory testing unit capable of performing
limited CL diagnostic procedures. It moves from one testing site to another, and it has a
DOH-licensed CL as its main laboratory.

National External Quality Assessment Scheme (NEQAS) — an EQAP activity conducted

by the National Reference Laboratories to assess the quality of performance and
accuracy of the results of laboratories.

National Reference Laboratory (NRL) — the highest level of laboratory in the country
performing highly complex procedures, including confirmatory testing, that is not
commonly performed by the lower level of laboratory. It is the responsible entity for
facilitating NEQAS to ensure compliance to quality standards for regulation and
all
licensing of laboratories in the Philippines.

Physician’s Office Laboratory (POL) — refers to a doctor’s office/clinic wherein CL

examinations are performed for the purpose of monitoring the doctor’s patients only,
wherein NO official results shall be issued. In this Order, POL within the premises of a
DOH-regulated facility shall be under the supervision of the CL.

Point of Care Testing (POCT) — refers to diagnostic testing done at or near the site of
patient care rather than in the CL. It may be in the emergency room, operating suites,
wards, and ambulances.

Satellite Clinical Laboratory (SCL) — refers to an extension of the main CL located

within the facility’s compound or premises. It shall have the same service capability as
the main laboratory.

Referral Tests — refers to CL tests that are either sent-out or outsourced to other DOH-
licensed CL with the same or higher service capability.

GENERAL GUIDELINES

A. All CL shall secure DOH-LTO prior to

its operation and must comply with the
minimum regulatory standards and requirements at all times.

The DOH-LTO shall be secured from the DOH regulatory office in accordance with
DOH guidelines.

Only DOH-licensed institution-based CL may have a SCL which shall be located within
the premises of the regulated health facility.

A DOH-licensed CL may have MCL services as listed in Section IV of Annex A,

provided, they adhere to the standard testing protocols.

The DOH-licensed CL shall not perform any examinations or testing beyond its
authorized service capability. However, it may be allowed to offer laboratory services
other than the respective stipulated minimum services, such as but not limited to, MCL,
SCL, confirmatory testing for Glucose-6-Phosphate Dehydrogenase (G6PD)
Deficiency, and Rapid HIV Diagnostic Algorithm (rHIVda), provided that the additional

1 ;
 services have been approved and indicated as add-on services in the DOH-LTO of the
CL.

Unit/Section of health facilities performing diagnostic CL tests such as, but not limited
to, arterial blood gas and/or Radioimmunoassay for thyroid function tests and Prostate
Specific Antigen shall be under the DOH-licensed CL.

The head of the CL shall be a pathologist certified by a professional organization

recognized as the Accredited Professional Organizations/Accredited Integrated
Professional Organizations of the Professional Regulation Commission. The head of
laboratory shall ensure the optimal overall operations and maintenance of the CL and if
applicable, of its SCL and MCL.

There shall be an adequate number of competent personnel assigned in the different

services provided by the DOH-licensed CL, which includes the MCL, SCL, remote
collection activities, if applicable.

CLs that are operated and maintained exclusively for research and teaching purposes
shall be required to register with the DOH-HFSRB.

The DOH designated NRL shall be covered by the license of the CL of the hospital
where they are affiliated with, Independent NRLs, or
those designated by DOH but are
not affiliated with any DOH-regulated health facility, shall secure a DOH-LTO from
HFSRB.

All CLs shall make their prices for laboratory services accessible to the public as
mandated by the UHC law and related DOH issuances.

At the Central Office, the Director IV, or in his/her absence or unavailability or when
delegated, the Director III of HFSRB, shall approve the issuance of the DOH-LTO of
the CL.

. At the CHD, the Director IV, shall approve the issuance of the DOH-LTO of the CL.

In the advent of new technologies or diagnostic platforms that shall affect the current
licensing standards for CL, Department Circulars shall be issued, as needed, as
supplements to this Order.

The CL shall be compliant with the prescribed standards and requirements (Annex A),
Assessment Tool for Licensing Clinical Laboratories (Annex B1 and B2) and other
relevant laws and issuances. These standards shall also apply to MCL and SCL.

The DOH-LTO may be revoked, suspended or modified in full or in part for any false
statement by the applicant, or as shown by the record of inspection or for a violation of,
or failure to comply with any of the terms and conditions and provisions of these rules
and regulations.
VI. SPECIFIC GUIDELINES
A. Classification of Clinical Laboratories
1. Classification by Ownership
a. Government — operated and maintained, partially or wholly, by the national
government, a local government unit (provincial, city or municipal), any other
political unit or any department, division, board or agency thereof.
b. Private — privately owned, established and operated with funds through
donation, principal, investment or other means, by any individual, corporation,
association or organization.
2. Classification by Institutional Character
a. Institution-based —a laboratory thatis located within the premises and operates
as part of a DOH licensed health facility.
b. Non-institution based — a laboratory that operates independently and is not
attached to any DOH licensed health facility.
3. Classification by Function
a. Clinical Pathology — deals with the chemical and cellular analyses of blood
and other body fluids (includes, but not limited to, clinical chemistry, clinical
microscopy, toxicology, therapeutic drug monitoring, immunology and
serology, hematology and coagulation), identification and examination of
microbes and parasites (bacteriology/parasitology/mycology/virology).
b. Anatomic Pathology — provides processing and examination of surgical
specimens as to the physical appearance and microscopic structure of tissues,
such as, but not limited to, surgical pathology, cytopathology,
immunohistochemical techniques, autopsies and forensic pathology.
¢. Molecular Pathology — deals with the analysis of certain genes, proteins and
other molecules in samples from organs, tissues or bodily fluids in order to
diagnose disease and/or to guide the prevention and treatment of disease based
on the principles, techniques and tools of molecular biology as they are applied
to diagnostic medicine in the laboratory.

4. Classification by Service Capability

a. Clinical Laborato for Clinical and Anatomic Patholo:

Provides the following Provides the Provides the Provides one (1) or
minimum service minimum service minimumservice two (2) specialized
capabilities: capabilities ofa capabilities ofa tests that are not
primary category, secondarycategory, classifiedunder
plus the following: plus the following: Anatomic or
Clinical - Urinalysis Molecular
Microscopy |- Fecalysis Pathology, as
- FecalOccult Blood Test exemplified below:
- Pregnancy Test (Rapid - Hormones
Test Kits — Lateral Flow) - Trace Metals
- Wet Smear for - Tumor markers
Trichomonas - Allergy Panel
Clinical - Fastingand Random - Serum - Other Clinical
Chemistry Blood Sugar Electrolytes Chemistry - This
- Oral Glucose Tolerance (Sodium, Examinations . ,
classification
Test Potassium,
-
Mo
Lipid Profile
. can
Chloride)
.
Hospital-based:
§ hall also appl.
PP
ALT Arterial Blood
To
to facilities
(TotalCholesterol, HDL, |-

LDL, Triglycerides) - AST Gases offering DOH-

- Creatinine programrelated
- Blood Urea Nitrogen tests, e.g.,
- Blood Uric Acid A
 Provides the following Provides the Provides the minimum Kato Katz for
minimum service minimum service service capabilities of Schistosomiasis,
capabilities: capabilities of a. | a secondary category, Malarial Smear,
primary category, plus the following: Filaria Smear,
plus the following: Slit-skin Smear,
Hematology - Complete Blood Count For Hospital-based Rapid Plasma
(Hemoglobin, - Coagulation Reagin for
Hematocrit, Red Blood studies (PT, Syphilis
Cell Count, White aPTT) :

Blood Cell Count with

Differential Count,
Quantitative Platelet
Count)
- Forward and reverse
ABO grouping and Rh
(D) typing (tube
method)
Serology/ - Dengue - Any machine-based
Immunology |- Syphilis serological and
- Hepatitis B immunological
(Screening) testing such as, but
- HIV (Screening) not limited to: tumor
Using Rapid Test Kits markers, thyroid
function tests and
hepatitis profile
Microbiology - TB (DSSM) or Nucleic
Acid Amplification
- Gram Stain
- KOH
- Culture and
sensitivity (aerobic
Test — for government and anaerobic)
facilities
Anatomic - Pap smear For Hospital-based:
Pathology - Cytology and
Histopathology

b. Clinical Laboratory for Anatomic Pathology only — provides services for any of
the following, but not limited to: cytology and histopathology.
¢. Clinical Laboratory for Molecular Pathology only — provides services for genetics,
immuno/hematopathology and infectious disease. COVID-19 testing laboratories
shall be covered by another Order.

PROCEDURAL GUIDELINES

A. Permit to Construct (PTC)

1. A completely filled out application form for DOH-PTC (downloadable at
www.hfstb.doh.gov.ph), whether manual or online, shall be submitted to the DOH
regulatory offices, as specified in Section V. B of this Order.

2. A DOH-PTC shall be required for construction of new CL and for renovation or

expansion of existing CL, including change in ownership and transfer of location.

1
3. The application shall be processed in accordance with the procedural guidelines set
forth in A.O. No. 2016-0042, also known as, “Guidelines in the Application for
Department of Health Permit to Construct (DOH-PTC).”
B. License to Operate (LTO)
1. Any person, firm or corporation desiring to establish, operate and maintain CL
shall submit an accomplished application form to HFSRB/CHD-RLED in
accordance with the current DOH guidelines, whether manual or through the
Online Licensing and Regulatory System (OLRS), once it
is fully functional.

A complete application for DOH-LTO of CL shall consists of the following:

a. Completely filled out application Form 1 and its attachments (downloadable
at www.hfsrb.doh.gov.ph);
i. Notarized Acknowledgement
ii. Any of the following proof of ownership and name of health facility
«+
DTI/SEC/CDA Registration including Articles of Incorporation/
Cooperation and By-Laws
+ Enabling Act/ LGU Resolution (for government health facility)
ili. Accomplished Self-Assessment Tool
iv. Health Facility Geographic Form
b. Copy of official receipt payment.
¢.
d.
Certificate from NRL-SLH/SACCL for rHIVdA Confirmatory, if
applicable.
Certificate from Newborn Screening Reference Center (NSRC), if applicable.

Upon receipt of the complete application forms, the HFSRB/CHD-RLED

representative, in accordance with the current DOH guidelines, reviews the
application and conducts an on-site assessment of the laboratory to determine full
compliance with the standards and technical requirements.

If, upon assessment, the laboratory is not fully compliant with the licensing
requirements, the HFSRB/CHD-RLED, in accordance with the current DOH
guidelines, shall provide a written report outlining the laboratory’s deficiencies.
The laboratory must comply with the deficiencies within thirty (30) days.
Otherwise, the application shall automatically be denied.

The DOH-LTO, whether initial or renewal, shall only be issued after the
HFSRB/CHD-RLED, in accordance with the current DOH guidelines, has
determined that the laboratory is fully compliant.

Submitted complete applications that are not processed within twenty (20) days by
the HFSRB/CHD-RLED, in accordance with the current DOH guidelines, due to
force majeure, shall automatically be granted the LTO, and a post-licensing visit
shall be scheduled.

Only DOH licensed CL identified by the program and has already secured a
certificate of “Certified rHIVda Confirmatory Laboratory (CrCL)” from the NRL-
SLH/SACCL or its designated regional counterpart, shall be allowed to apply for
a license CrCL.

A DOH-licensed hospital-based tertiary CL, already certified by the NSRC, may

apply as a G6PD Deficiency confirmatory laboratory to HFSRB.

institution-based CL, the One-Stop Shop (OSS) Licensing System, pursuant to

For
Administrative Order No. 2018-0016 dated June 4, 2018, titled “Revised
Guidelines in the Implementation of the One-Stop Shop Licensing System,” shall

1
 10. The DOH-LTO is non-transferable and a new application for DOH-LTO shall be
required in case of change of ownership or transfer of location.

11. The HFSRB/CHD-RLED, in accordance with the current DOH guidelines, shall
be notified in writing of any change in management name, ownership, or headship
or laboratory personnel. Failure to notify of any substantial change in the condition
of the laboratory, i.e. changes in the physical plant, equipment, or personnel, in
writing within fifteen (15) days, may be a basis for the suspension or revocation of
the DOH-LTO.

12. Different branch(es) of a CL, even if owned by the same entity shall secure separate
DOH-LTO.

13. Application for DOH-LTO shall be in compliance with AO No. 2019-0004 dated
April 30, 2019, titled “Guidelines on the Annual Cut-off Dates for Receipt of
Complete Applications for Regulatory Authorizations Issued by the Department of
Health.”

14. The DOH-LTO shall be placed in an area that can be readily seen by the public, at
all times.

C. Certificate of Registration (COR)

1. COR
is
required for research and teaching laboratories.

2. Applicants shall submit an accomplished registration form (downloadable at

www.hfsrb.doh.gov.ph) together with the necessary attachments to HFSRB, which
includes Annex for services.

3. The applicant shall be required to pay a non-refundable application fee before

submission of the requirements as part of complete application.

4. The HFSRB shall evaluate and accept applications based on the due execution of
forms and completeness of attachments.

D. Validity
1. The DOH-LTO is valid for one (1) year.

2. COR
for CL that is operated and maintained exclusively for research and teaching
shall be with the DOH-HFSRB three
purposes required to register every (3) years.

E. Fees
1. All fees shall follow the prescribed fees by the DOH.

2. All fees/checks shall be paid to the order of DOH Central Office/ CHD Cashier,
whichever is applicable in person, through postal money order or online payments
approved by the DOH.

F. Monitoring
1. Authorized representatives from the HFSRB/CHD-RLED in accordance with the

es
current DOH guidelines, may conduct unannounced on-site visits of licensed CL
and registered research and teaching laboratories to monitor and document the

/
continuous compliance of the CL to the set

8
 If upon monitoring visit, the CL is found to be violating any of the rules and
regulations stated herein relative to its operation, the HFSRB/CHD-RLED in
accordance with the current DOH guidelines, may immediately impose preventive
suspension.

CL that are operated and maintained exclusively for research and teaching
purposes shall not issue official results for diagnostic purposes. They may be
monitored to ensure that they are not operating beyond allowed capabilities.

VIII. ROLES AND RESPONSIBILITIES

A. Health Facilities and Services and Regulatory Bureau shall;

I. Set standards for the regulation of CL and strictly enforce the provisions of this
Order.

Disseminate regulatory policies, standards and forms for information and

guidelines of the DOH-CHDs.

Provide consultation and technical assistance to stakeholders, including regulatory

officers from the DOH-CHD:s in line with the regulation of CL.

Respond promptly to complaints relative to the operation of CL under its

jurisdiction.

B. Center for Health Development — Regulatory, Licensing, and Enforcement Division

shall;
1. Strictly enforce the provisions of this Order.

2. Submit quarterly report on Suspension/Revocation/ Cease and Desist Order issued

on CL not later than the 15th day of the following month after the covered quarter.

Provide consultation and technical assistance to stakeholders in line with the

regulation of CL.

Respond promptly to complaints relative to the operation of CL under its

jurisdiction.

C. National Reference Laboratories shall;

1. Provide laboratory reference/referral services for confirmatory testing.

2. Train laboratory personnel and recognize other training institutions.

3. Maintain the National External Quality Assessment Scheme (NEQAS).

4. Perform technical evaluation of reagents and diagnostic kits.

D. DOH-Licensed Clinical Laboratories shall;

1. Continuously comply with the rules and regulations, licensing standards and
requirements for CL, as provided in this Order and related issuances.
 2. Participate in EQAP that may be administered by a designated NRL or other local
and international EQAP approved by the DOH, surveys and other activities that
will be required from them by the DOH.

3. Intimes of Pandemic of Public Health Event, be mandated to submit timely reports

and data.

IX. VIOLATIONS, SANCTIONS AND APPEAL

A. A CL shall be sanctioned and penalized by the HFSRB/CHD Director upon violation
of any of these guidelines and its related issuances and laws, or upon committal
(commission/omission) of prohibited acts (Annex C) by the persons owning or
operating the CL, and/or the persons under their authority.

For non-institution-based CL that are not under the OSSOLS, the following are the
penalties and sanctions that shall be imposed for the commission of any of the violations
in this Order and other relevant issuances:
i. 1% offense: Stern warning
ii. 2" offense: Thirty thousand pesos (Php 30,000.00)
ili. 3" offense: Fifty thousand pesos (Php 50,000.00)
iv. 4% offense: Revocation of DOH-LTO

For CL that are part of hospitals and other facilities that are subject to comply with the
OSS licensure system, AO No. 2007-0022, dated June 6, 2007, titled “Violations under
the One-Stop Shop Licensure System for Hospitals,” sanctions shall be governed by the
aforementioned Order.

Any person who operates a CL without securing the necessary DOH-PTC and
corresponding DOH-LTO shall be issued a Cease-and-Desist Order (CDO) and shall
pay the administrative penalty of Fifty thousand pesos (Php50,000.00).

Section 4 of Republic Act No. 4688 shall still be imposable aside from the
administrative penalty provided in this Order.

In case of complaints, the CL, upon receipt of such by HFSRB/CHD-RLED shall be

given due process wherein an investigation shall be conducted and the appropriate
sanctions forits violation/s. A 60-day preventive suspension may be given to the CL
during the investigation depending on the seriousness of the violation.

Any CL or any of its personnel not amenable with the decision of the HFSRB/CHD-
RLED may, within ten (10) days after the receipt of notice of decision, file a notice of
appeal to the Head of the Health Regulation Team (HRT). All pertinent documents and
records of the appellant shall then be elevated by HFSRB/CHD-RLED to the HRT. The
decision of the Head of the HRT, if still contested may be brought on a final appeal to

a
the Secretary of Health, whose decision shall be final and executory.

CL with revoked licenses can only re-apply after one year from the date of LTO
revocation.

Any person authorized or licensed to conduct clinical laboratory tests, who issues false
or fraudulent laboratory test results knowingly, willfully or through gross negligence
shall not be allowed to own, manage, operate, or be an analyst of
CL.
1
10
 X. TRANSITORY PROVISIONS

A. All existing licensed CL shall be given three (3) years to comply with the physical plant
requirements from the date of effectivity of this Order.

B. All existing licensed CL shall be given two (2) years to fully offer the additional
services for each category with corresponding personnel and equipment from the date
of effectivity of this Order.

C. For new CL, this Order shall be immediately applicable.

D. For CL currently headed by Anatomic Pathologists with an associate Clinical

Pathologist or Clinical Pathologists heading tertiary CL with Anatomic Pathology
services, such headships shall be retained until his/her eventual retirement, resignation
or replacement. Thereafter, all CL shall be headed by a pathologist certified in Clinical
Pathology by the Board of Pathology of the Philippine Society of Pathologists, except
for tertiary CL with anatomic pathology service which shall be headed by a pathologist
certified in both Anatomic and Clinical Pathology.

XI. REPEALING CLAUSE

These rules and regulations shall rescind Administrative Order No. 2007-0027 titled
“Revised Rules and Regulations Governing the Licensure and Regulation of Clinical
Laboratories in the Philippines,” all administrative orders and previous issuances
inconsistent thereof,

XII. SEPARABILITY

In the event that any provision or part of this Order be declared unauthorized or rendered
invalid by any court of law or competent authority, those provisions not affected by such
declaration shall remain valid and effective.

XIII. EFFECTIVITY

This Order shall take effect fifteen (15) days following its publication in a newspaper of
general circulation and upon filing three (3) copies to the University of the Philippines Law
Center.

T. DUQUE III, MD, MSc

Sedretary of Health

11
 A.0.No.2021- (0) ]
Republic of the Philippines ANNEX A
Department of Health

LICENSING STANDARDS FOR CLINICAL LABORATORY

I. PHYSICAL PLANT
Every clinical laboratory (CL) shall have an adequate space for its operation to safely,
effectively and efficiently provide services to clients.

A. The CL shall conform to all applicable local and national regulations for the
construction, renovation, maintenance and repair of CL.

B. The laboratory shall conform to the required space for the conduct of its activities.
Personnel, fixtures, equipment, sink, etc. shall also be considered. Minimum area
requirements for each are listed in Annex D.

C. There shall be well-ventilated, lighted, clean, safe and functional areas based on the
services provided.

D. There shall be a program of proper maintenance and monitoring of physical plant and
facilities.

E. There shall be policy guidelines on laboratory biosafety and biosecurity which includes
risk assessment that will serve as the basis of biosafety level required for the specific
CL.

F. There shall be an area for confirmatory testing for Rapid HIV Diagnostic Algorithm
(CrCL) and Glucose-6-Phosphate Dehydrogenase (G6PD) Deficiency which may be a
section, unit, or division integrated in a DOH licensed CL, if applicable.

II. PERSONNEL
Every CL shall have an adequate number of trained personnel, depending on the workload,
to provide safe, effective and efficient services to clients.

A. Head of the Laboratory (HOL)

1. The head of the laboratory shall be a competent and experienced professional,
with a specialized skill set related to and proportionate to the laboratory category,
to ensure that the laboratory runs efficiently. The head of the laboratory is
essentially responsible for the operation of the entire laboratory, its personnel,
functions, and data, all of which shall meet the quality assurance criteria and
regulatory requirements.

2. The head of the laboratory shall oversee the operation of the CL and have
administrative and technical supervision of the activities including the mobile
clinical laboratories (MCL), remote collection activities, and point of care testing
(POCT), if applicable.
3. The head of the laboratory shall supervise the staff in accordance to the standards
set by the Philippine Society of Pathologists.
pd 1
 4. The head of the laboratory shall visit once a month and at least twice a week of
supervisory calls and/or videoconferencing OR at least once a week physical visit.
For hospital-based DOH licensed CL, it
visits shall have to be well documented.
shall be once a week physical visit. The

For Geographically Isolated and Disadvantaged Areas (GIDAs) with no clinical

pathologists, as certified by the Philippine Society of Pathologists, board certified
Anatomic Pathologists or Physicians with complete training in Clinical
Laboratory Medicine, Quality Assurance and Laboratory Management, may head
one primary DOH licensed CL.

B. Registered Medical Technologist (RMT)

1. There shall be an adequate number of full-time RMTSs to conduct the laboratory
procedures, including those assigned in MCL. The number of staff shall depend
on the workload and the services being provided.

. There shall be staff development and continuing education program at all levels
of organization to upgrade the knowledge, attitude and skills of staff.

There shall be a designated Biosafety and Biosecurity Officer in-charge primarily

of the risk assessment of the DOH licensed CL.

C. Support Staff
1. There shall be an adequate number of support staff such as, but not limited to
laboratory technician, laboratory aide, encoders, and receptionists when
applicable.

D. POCT Coordinator — if applicable

1. A senior staff from the CL shall be designated as a POCT coordinator who shall
have the following functions, but not limited to:
a. Recommends procedures that will ensure the quality of results of POCT in
consultation with the pathologist.
b. Ensures that POCT machines/device and kits are properly maintained.
¢. Supervises the operators of POCT device/machine.
d. Ensures that the operators have appropriate trainings and checks the
competency of the operators regularly.
e. Ensures that quality control (QC) is implemented and reviews POCT QC
results periodically, depending on the number of
tests.

E. POCT Operator — if applicable

1. The designated operator of the POCT device/machine and testing kits shall have
the following functions, but not limited to:
a. Ensures accurate results of POCT.
b. Ensure that POCT machines/device and kits are properly maintained and
stored.
c. Run tests on quality control at least once each day or as recommended by the
manufacturer.
d. Initially, implements quality assurance program or contact the manufacturer’s

Te
application specialist for assistance, when a POCT machine/device is not
properly functioning or the control sample is in out of control range.
e. Reports to the supervising CL any untoward concerning
POCT.
)
 F. MCL Personnel
1. MCL shall has its own set of personnel, which includes the following but not
limited to:
a. Registered Medical Technologist — number will depend on the anticipated
workload.
b. Support staff such as, but not limited to, driver and laboratory technician.

III. EQUIPMENT/INSTRUMENTS/REAGENTS/GLASSWARES/SUPPLIES
Every CL shall have an adequate equipment, instruments, reagents, glassware and supplies
which are all in good working condition and sufficient for the operations.

A. There shall be available and operational equipment/machines/devices to provide the

laboratory examination that the laboratory is licensed for.

B. There shall be a calibration, preventive maintenance and repair program for every
equipment/machines/instruments/devices in the DOH licensed CL.

C. There shall be a contingency plan in case of equipment/machines/devices breakdown

and malfunction.

D. There shall be adequate available reagents, glassware and supplies for the laboratory
examinations.

E. There shall be an inventory control of the reagents, glassware and supplies.

F. The reagents, glassware and supplies shall be properly stored under the required
conditions.

G. The machines/devices, reagents and test kits that are used in the CL and MCL as well
as POCT shall be approved by the Philippine Food and Drug Administration and
validated by the proper government institutions (e.g. National Reference Laboratory).

H. The MCL shall have its own set of functional, and operational equipment, as well as
its own set of supplies.

IV. SERVICE DELIVERY

The services provided by the CL shall ensure quality and safety to clients, to its personnel
and to the general public.

A. All CL shall ensure that the service being delivered to patients must comply with the
standards and other related relevant issuances.

B. Mobile Clinical Laboratory

1. The collection site/area for MCL shall be located within the same region, at a
maximum of one hundred (100) kilometer radius, from the address of the DOH
licensed CL.
pH 9
 2. Aside from specimen collection for different tests within the service capability of
the main CL, the MCL shall be allowed to perform the following on-site tests
which shall be declared in the LTO of the main CL:
gop
Urinalysis
Fecalysis
Pregnancy Test (lateral flow)
ae
Basis Serologic Test using Rapid Test Kits — Dengue, Screening of Hepatitis
B, RPR/Syphilis Test, and HIV

Specimen collected for other test, not mentioned above (Section IV. B. 2), should
be properly handled and transported. Serum blood samples for chemistry testing
must be separated within four (4) hours from the time of collection.

V. INFORMATION MANAGEMENT
Every CL shall maintain a system of communication, recording, reporting and releasing of
results.

A. Administrative Policies and Procedures

1. The CL shall have written policies and procedures for the provision of laboratory
services, the operation and maintenance of the CL, which includes satellite
laboratories, MCL and POCT, and shall include the accountabilities of every
personnel working in the laboratory.

There shall be documented technical procedures for services provided in each

section of the laboratory, including MCL and POCT, which will ensure the quality
of laboratory results.

3. There shall be a risk assessment for every section in the CL.

B. Communication and Records Management

1. The CL shall maintain and ensure the confidentiality of all records.

2. There shall be procedures for the receipt and performance of routine and STAT
requests for laboratory examinations.

There shall be procedures for the reporting of results of routine and STAT
laboratory examinations, including critical values that would impact on patient
care.

All results shall be released in accordance with DOH guidelines.

All laboratory reports on various examinations of specimens shall bear the name,
PRC registration number, and original signature of the registered medical
technologist(s) who performed the laboratory examinations, and the pathologist
who shall be accountable for the reliability of the results.

There shall be a policy guideline on the use of digital signature. The use of digital
signature for laboratory results shall be permitted only if properly authenticated
by the Department of Information and Communication-Philippine National Public
Key Infrastructure. The use of digital signature shall also be in accordance with
the provisions of the E-Commerce Law.
1
 7. There shall be procedures for the reporting of workload, quality control, inventory
control, work schedule and assignments.

8. There shall be procedures for the reporting and analysis of incidents, adverse
events, and in handling complaints.

9. The retention of laboratory documents, records, slides and specimens shall be in

accordance to the standards promulgated by the DOH or by competent authorities
for such purposes.

10. The operating hours of the CL shall be known to its clients.

11. The CL which supervises the POCT shall have a master list of the following, but
not limited to:
a. Name and designation of operators, and,
b. POCT machines, instruments and kits.

VI. QUALITY IMPROVEMENT

Every CL shall establish and maintain a system for continuous quality improvement
activities.

A. There shall be an Internal Quality Assurance Program which shall include:

1. An Internal Quality Control Program for technical procedures.

2. An Internal Quality Assurance Program for inputs, processes and outputs.

3. A Continuous Quality Improvement Program covering all aspects of laboratory

performance.

B. The CL shall participate in External Quality Assessment Program (EQAP) that may be
administered by a designated NRL or other local and international EQAP approved by
the DOH.

C. A periodic assessment shall be conducted by representatives from the top management,

clinical laboratory, clinical departments and nursing service, to evaluate the policy of
the CL on POCT.

VII. REFERRAL OF LABORATORY EXAMINATIONS

Every CL shall ensure the quality of services provided through an agreement, or its
equivalent, to a DOH licensed CL performing the laboratory services needed.

A. The referral laboratory must be a DOH-licensed CL. They shall have a Memorandum of
Agreement (MOA) with the referring CL and shall be responsible for the collection,
transport and processing of specimens, and releasing of results.

B. A separate MOA is required when referred tests, which are not within the service
capability of the CL, unless the referral is part of the contingency plan.
Al 1
 A MOA prescribing the accountabilities of each party, shall be secured when laboratory
examinations are referred to and provided by another DOH-licensed CL.

Referral of examinations to other DOH-licensed CL are only permitted in the following

circumstances:
1. If the laboratory test to be sent out
is
not part of the service capability expected
for the particular category of the referring laboratory; and,

2. Ifreferral of laboratory is
part of the contingency plan, in cases of equipment
test
breakdown, of the referring CL, this shall be for a certain limited period of time
only, which shall not last for more than 3 months. This shall be properly
documented.

VIII. ENVIRONMENTAL MANAGEMENT

Every CL shall ensure that the environment is safe for its patients and staff, including the
general public.

A. There shall be a program of proper maintenance and monitoring of physical facilities.

B. There shall be procedures for proper disposal of infectious wastes and toxic and
hazardous substances in accordance with RA 6969, also known as “Toxic Substances
and Hazardous and Nuclear Wastes Control Act of 1990” and other related policy
guidelines and/or issuances.

There shall be a “No smoking policy” and that the same shall be strictly enforced.

There shall be a contingency plan in case of accidents and emergencies.

4
There shall be a policy for biosafety and biosecurity.

There shall be policy guidelines on infection prevention and cond

7
 A.0. No. 2021-0037
ANNEX C
Republic of the Philippines
Department of Health
HEALTH FACILITIES AND SERVICES REGULATORY BUREAU

PROHIBITED ACTS IN THE OPERATIONS

OF CLINICAL LABORATORIES

Sanctions and penalties will be based on Section IX. B of the Administrative Order

A. The Clinical Laboratory (CL) may be sanctioned or penalized upon commission of

the following prohibited acts and violations:

I. Refusal to allow HFSRB/CHD-RLED authorized personnel to conduct inspection or

monitoring visits of the clinical laboratory at any appropriate time;

2. Refusal or nonparticipation of any CL in an External Quality Assessment Program

(EQAP) provided by a designated NRL or other local and international EQAP
approved by the DOH;

3. Absence of action to improve the unsatisfactory or failed EQAP administered by a

designated NRL or other local and international EQAP approved by the DOH;

4. Demonstrating incompetence or making consistent errors in the performance of CL

examinations and procedures;

5. Deviation from the standard test procedures including use of expired reagents;

6. Issuance of a laboratory report without the approval of the head of the laboratory;

7. Transferring of laboratory results done by another laboratory to the result form of the
referring laboratory;

8. Performing laboratory procedures beyond their authorized service capability; and,

9. Giving and receiving any commission, bonus, kickback or rebate or engaging in any
split-fee arrangement in any form whatsoever with any facility, physician,
organization, agency or person, either directly or indirectly, for patients referred to a
CL
licensed by the DOH.
10. Violation of provisions in the Republic Act No. 10173 or the Data Privacy Act of 2021.

B. The DOH_LTO will be revoked immediately after commission of the following

prohibited acts and violations:
1. Permitting unauthorized or unregistered personnel to perform technical procedures and
access to laboratory records/data;

2. Lending or using the name of the DOH-licensed CL or the head of the laboratory or
medical technologist to an unlicensed CL;
)
 3. Unauthorized use of the name and signature of the pathologist and RMT to secure
LTO;

4. Issuance of fraudulent laboratory results, or tests not actually done or inaccurate

results;

5. Change in the ownership, location, and head of the laboratory or laboratory personnel
without informing the HFSRB/CHD-RLED; and,

6. Any material false statement in the application of LTO.

C. Other violations similar or analogous to the above will be sanctioned and penalized
accordingly.
dl